(NaturalNews) Several members of Congress are up in arms over the U.S. Food and Drug Administration (FDA)'s recent crackdown on faulty drug manufacturing facilities across the country. According to the Washington Examiner and several other news outlets, House Oversight and Government Reform Committee (HOGRC) Chairman Darrell Issa (R-Cal.) has issued a public statement in protest of the FDA's regulatory actions, dubbing them "over-aggressive and excessive," and responsible for causing widespread shortages of "life-saving" drugs.
Dozens of drugs have had to be recalled just within the past year due to contamination, production, labeling, and dosage problems, which is why the FDA sent out 1,720 warning letters to drug companies -- the agency only sent out 474 warning letters in 2009 -- notifying them that changes needed to be made. But now Congress has turned the issue into a partisan one, and is actually accusing the FDA of doing too much in trying to protect the public from unsafe drugs.
Rep. Issa flip-flops on FDA enforcement actions
As many NaturalNews readers will remember, McNeil Consumer Healthcare, a division of Johnson & Johnson (J&J), voluntarily shut down its Fort Washington, Penn., facility back in 2010 after a series of drug recalls that included several million containers of various children's medicines. (http://www.naturalnews.com/030504_Johnson_&_recalls.html) It turned out that the McNeil manufacturing plant producing these medicines was infested with bacteria and filth. (http://consumerist.com)
At that time, Rep. Issa and several others issued a joint statement expressing concern about the filthy conditions at the McNeil plant, and actually indicted the FDA for allegedly failing to conduct proper inspections and recall procedures that Rep. Issa and others implied would have kept the public safe from the tainted products. (http://www.ipqpubs.com) Now, however, more than two years after his previous statements, Rep. Issa is singing a different tune, claiming that the FDA is doing too much to protect the public.
According to Rep. Issa, drug companies are having to slow or even stop production of certain "life-saving" drugs in order to come into compliance with FDA standards. So putting the lives of millions of patients at risk from exposure to tainted drugs is apparently not that big of a priority anymore since the FDA's regulatory actions are now cutting into Big Pharma's profit margins -- or as Rep. Issa and his cohorts have put it, "failing to ensure the availability of quality products."
So when the FDA steps in to stop drug companies from dispensing contaminated drugs, the agency is needlessly obstructing the nation's supply chain of critical drugs, in Rep. Issa's opinion. But when the FDA pursues supplement manufacturers, threatens walnut and cherry growers, and shuts down family farms (http://www.naturalnews.com/033280_FDA_raids_timeline.html" target="_blank">http://www.naturalnews.com/033280_FDA_raids_timeline.html), it is apparently just business as usual in the corrupt world of regulatory politics.
Rep. Issa was nowhere to be found when the FDA needlessly destroyed the entire business of Pennsylvania Amish farmer Dan Allgyer, obstructing access to that area's supply chain of raw milk. (http://www.naturalnews.com/035000_Amish_farmers_raw_milk_feds.html) He was also nowhere to be found when the FDA participated in a SWAT-style raid on Rawesome Foods near Los Angeles, Cal., which interfered with that local area's supply chain of organic, natural, and untainted foods. (http://www.naturalnews.com/033220_Rawesome_Foods_armed_raids.html)
For once, the FDA is actually doing a decent job of pursuing the dirty players in the drug industry, and Rep. Issa and others in Congress are complaining that these actions are inappropriate. It just goes to show how deeply corrupted the American political system has become.
Sources for this article include:
http://campaign2012.washingtonexaminer.com
http://in.reuters.com
http://www.forbes.com
Learn more: http://www.naturalnews.com/036390_drug_factories_FDA_violations.html#ixzz1ztnNOXfE
This article can be found here.
Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Friday, July 6, 2012
Complaint Filed in K-V v. FDA, case number 12-01105
The Complaint filed in K-V Pharmaceuticals v. FDA can be viewed here.
The Motion for Temporary Restraining Order and Preliminary Injunction can be viewed here.
Exhibits to the complaint can be viewed here.
The declaration of Scott Goedeke can be viewed here.
The declaration of Michael Jowiakowsk can be viewed here.
The declaration of Thomas McHugh can be viewed here.
The declaration of Patrick Ronan can be viewed here.
The proposed order for the temporary restraining order can be viewed here.
The proposed order for the permanent injunction can be viewed here.
The Motion for Temporary Restraining Order and Preliminary Injunction can be viewed here.
Exhibits to the complaint can be viewed here.
The declaration of Scott Goedeke can be viewed here.
The declaration of Michael Jowiakowsk can be viewed here.
The declaration of Thomas McHugh can be viewed here.
The declaration of Patrick Ronan can be viewed here.
The proposed order for the temporary restraining order can be viewed here.
The proposed order for the permanent injunction can be viewed here.
Deadlines in K-V v. FDA
On July 5, 2012, the district court entered a minute order, setting the following deadlines:
On July 6, 2012, the district court entered the following additional deadlines:MINUTE ORDER. Based on the matters discussed with counsel for the parties at a telephone conference held on this date, it is ORDERED that pursuant to Fed. R. Civ. P. 65(a)(2), the motion for temporary restraining order and preliminary injunction [Dkt. # 2] will be consolidated with the merits. It is FURTHER ORDERED that the matter will be briefed in accordance with the following schedule: defendants' dispositive motion and combined memorandum in opposition to plaintiffs' motion and in support of its dispositive motion shall be filed on or before July 20, 2012; plaintiffs' combined reply and opposition to the dispositive motion shall be filed on or before July 27, 2012; defendants' reply in support of its dispositive motion shall be filed on or before August 3, 2012; and a motions hearing is set for August 7, 2012, at 2:00 pm. Since plaintiffs' motion is now consolidated with the merits, the parties need not brief irreparable harm. Signed by Judge Amy Berman Jackson on 7/5/12.
Set/Reset Deadlines/Hearings: Defendants' Dispositive Motion and Opposition to Plaintiffs' motion is due by 7/20/2012; Plaintiffs' combined Reply and Opposition to Defendants' Dispositive Cross Motion is due by 7/27/2012; Defendants' Reply in support of its Dispositive Cross Motion is due by 8/3/2012; Motions Hearing scheduled for 8/7/2012 at 2:00 PM in Courtroom 3 before Judge Amy Berman Jackson.
India Weighs Providing Free Drugs at State-Run Hospitals
By VIKAS BAJAJ
Published: July 5, 2012
MUMBAI, India — In what would be a landmark increase
in the Indian government’s spending on public health, New Delhi is completing a
proposal to provide hundreds of essential drugs free to patients in
government-run hospitals and clinics at a cost of nearly $5 billion over five
years, officials said Thursday.
To read remainder of article, click here.
Thursday, July 5, 2012
House Committee Report Finds Fault with FDA on Drug Shortages
House Committee Report Finds Fault with FDA on Drug Shortages
ly 5, 2012 By Anthony Nguyen Leave a Comment
According to a House Committee on Oversight and Government Reform report, the blame for the recent nationwide shortages of critical drugs, especially in oncology agents, resides largely with the FDA.
The June 15, 2012, report notes that since 2010, “the FDA has failed to ensure that enforcement and compliance activities are conducted in a manner that does not create unnecessary shortages of critical drugs.” Interestingly, the committee seemed to correlate FDA’s activities and the drug shortages with the appointment of current FDA Commissioner Margaret A. Hamburg to the position.
In discussing FDA actions compounding drug shortages, the committee stated that when the FDA responds to a manufacturing problem involving producers of generic injectable drugs, the result is that “companies producing generic injectable drugs have taken their manufacturing off-line simultaneous to other generic competitors also going off-line.” The simultaneous shutdowns of these generic manufacturers impact the supply stream.
As a result, the FDA’s actions are viewed as regulatory interference in the production process. The committee attributed the agency’s actions as essentially forcing the shutdown of 30 percent of the total manufacturing capacity of four of the largest manufacturers of injectable drugs: Bedford Laboratories, Hospira Pharmaceuticals, Sandoz Pharmaceuticals, and Teva Pharmaceuticals.
Drug shortages in general have garnered attention from the administration, as President Obama issued an executive order late last year to spotlight and attempt to address the problem. In December, the Government Accountability Office recommended that the FDA be allowed to mandate that drug companies be required to warn the agency when they think a shortage of a particular drug is imminent, so plans could be made to alleviate the shortage. That idea was incorporated into the Senate version of the recently passed user fee bill.
The House committee recommended that when problems that are not an immediate public safety threat are detected at drug manufacturers, facilities should be directed to make targeted improvements under close FDA investigation. The belief is that this approach would be more appropriate then shutting down manufacturing lines in its entirety.
However, the committee suggested that proposals to let drugmakers share information about their manufacturing capabilities and product availability might be worth considering, although that might leave open the possibility for collusion among the companies.
Exit the dragon Indian drug makers are trying to shake off their dependence on China
Geetanjali Shukla Edition: May 27, 2012
It's a no-brainer that buying from a Chinese supplier is cheaper than from a Japanese one, right? Pravin Herlekar, Chairman of Omkar Speciality Chemicals, a Rs 100-crore bulk drug maker based in Badlapur, near Mumbai, learned the hard way that it is not always true. His company dumped its Japanese supplier of selenium when it found a cheaper source in China. But, Herlekar says, the Chinese suppliers resisted inspection of shipments before delivery. Within a few months, the intermediates that Omkar made using Chinese selenium began to suffer from quality issues. The company went back to sourcing selenium from Japan.
"Chinese suppliers often don't agree to third party inspections which help keep a check on quality," says Herlekar. Selenium derivatives are used to make an active pharmaceutical ingredient (API) or bulk drug. Bulk drugs are used to make medicines. For instance, intermediate compounds such as isobutyl benzene, aluminium chloride and sodium dichromate are used to make ibuprofen, the principal ingredient in formulation brands such as Combiflam.
With strong advantages such as economies of scale and government funding, Chinese companies have been flexing their muscles by resisting inspections, neglecting quality issues and raising prices. Many Indian companies are finding or creating alternatives to Chinese suppliers"
Lower prices offered by Chinese companies have caught the attention of many Indian drug makers. "In the last five years, API imports by Indian companies have doubled. In 2010/11, imports crossed $7 billion, of which China has a 60 per cent share," says O.R.S. Rao, Director, Cygnus Business Consulting and Research. "In the same period, India's bulk drug production has fallen to 35 per cent of its consumption, from about 70 per cent." The Hyderabad-based research firm releases a study on the Indian bulk drug industry every two years; the last edition was published in 2011. The Indian bulk drug market is valued at $13.5 billion, and its Chinese counterpart at $30 billion.
China and India are the leading players in bulk drugs, accounting for more than 40 percent of global bulk drug production. China is the largest bulk drug supplier, and India is second. Part of China's competitive advantage comes from the operating environment (lower interest rates, access to power and other infrastructure) and government aid (cheaper land, government funding). This has enabled Chinese manufacturers to benefit from economies of scale. China is also better endowed with raw materials such as phosphorous, potassium and sulphur. So it can produce bulk drugs at 10 percent of the cost in developed countries.
In 2010/11, bulk drug imports by Indian companies crossed dollar 7 billion, of which China has a 60 per cent share: O.R.S. RaoGiven their strong advantages, Chinese companies have been flexing their muscles by not allowing inspections, neglecting quality issues and raising prices. And Indian pharma seems to have finally decided that it needs to stop depending on China. Some Indian companies are integrating their operations backward to increase control over bulk drugs and intermediates. And, as price increases by Chinese manufacturers squeeze margins, Indian companies are trying to move up the value chain into the high-margin formulations business. Dependence on China has generated enough concerns for the Indian Drug Manufacturers' Association (IDMA) to call for anti-dumping duties on some bulk drugs and intermediates from China. IDMA also wants the government to set up a $700-million fund for bulk drug manufacturers. "Low-priced Chinese APIs are attractive, but this phenomenon can only be temporary," says Manish Doshi, President, IDMA.
"Nothing can stop them from raising prices once they know that Indian API manufacturers have closed down due to cut-throat competition. It is the government's duty to protect the industry from such dumping tactics by China." Doshi is also Managing Director at Amoli Organics and Umedica Laboratories, companies which were set up by his father and which make intermediates, bulk drugs and finished drugs. Naresh Gupta, who heads Lupin Laboratories's bulk drug unit, also argues that the government should try to level the playing field for Indian manufacturers. Incidentally, Lupin is the only Indian pharma major that exports bulk drugs to China.
Omkar Speciality Chemicals isn't waiting for the government act, however. Its strategy is to meet international standards. Its Badlapur factory has good manufacturing practices (GMP) status from the US Food and Drugs Administration. Regulatory authorities in many countries grant GMP status, but the most important for Indian companies are the US and British authorities, besides Indian regulators. Omkar will also seek GMP status for its factory coming up in Chiplun, Maharashtra. Herlekar says his advantage will be quality. "Indian formulations majors are increasingly sourcing from India, as they don't have to maintain large stocks and quality can be controlled," he says. "Most Indian API and intermediates manufacturers get their facilities audited by their customers, so quality isn't much of an issue."
Another strategy is backward integration. Shasun Chemicals and drugs, a Chennai-based Rs 1,000-crore company, has decided to manufacture some intermediates at its Andhra Pradesh plant, rather than importing them from China. Managing Director S. Abhaya Kumar says: "We have earmarked Rs 70 crore to move production of some of our key intermediates to India. The shift should be complete by December." He adds that intermediate prices in China have increased by 10 per cent in the last three months, because of rising petroleum prices and pressure on China to adhere to environmental norms. Shasun is the largest producer of ibuprofen in the world. It is developing 13 APIs for a few billion-dollar drugs whose patents expire in the next five years.
Another way to integrate backward is to acquire a bulk drug maker. For example, Mumbai-based Aanjaneya Lifecare bought intermediates manufacturer Apex Drugs in February for Rs 250 crore. The aim is to reduce dependence on third parties and reduce its vulnerability to fluctuations in price and supply. Similarly, Indoco Remedies, also based in Mumbai, acquired bulk drug maker La Nova Chem in 2006. The contribution of bulk drugs to overall revenues is negligible, but Indoco plans capital expenditure of Rs 55 crore over the next couple of years in its bulk drug factory at Patalganga, near Mumbai.
To counter the Chinese, big Indian drug makers such as Dr. Reddy's, Ranbaxy and Lupin have been moving up the value chain, from intermediates and bulk drugs to generics. But not everyone finds it easy to walk away from China.
"Only intermediates that have an impact on the quality of the finished product are manufactured in India or inhouse," says Sanjay Bhanushali, Head of International Business at Cipla. Procurement from China has increased five to eight per cent every year for the last three years." Cipla is looking at stronger alliances with other Indian or overseas companies to avoid sudden shocks. It is also open to dealing with companies in other markets, such as Brazil, Argentina, and Vietnam.
Lupin's Gupta says his company's Japanese operations are looking to shift all bulk drug manufacturing to India. "Despite price volatility in some inputs, the company was able to insulate itself due to hedging," he adds. Quality and research differentiate India from China. India has more than 175 plants approved by the US FDA - the highest number outside the US. Focus on quality has helped Indian companies increase their presence in developed markets. According to a report published in April by HSBC Global Research, half the Drug Master Files (DMF) in the first three months of this year are from Indian companies, compared to China's share of 14 per cent. DMF documents contain complete information about a drug's chemistry and manufacturing process, among other things, and enable a company to protect its intellectual property.
Many medium-sized bulk drug manufacturers have, with investments in research and development, shifted focus to late-stage intermediates and complex synthetic APIs. Chandigarh-based Parabolic Drugs , a Rs 900-crore company, recently commissioned a facility to manufacture bulk drugs in new therapy areas such as oncology and lifestyle ailments such as diabetes. The facility is likely to generate revenues of Rs 50 crore to Rs 75 crore in the current financial year and when fully operational, can generate up to Rs 300 crore.
But in the near future, it looks as if Chinese companies will continue to bleed Indian bulk drug makers. The capital-intensive nature of operations and extended working capital cycles have suppressed their return on capital. "Many bulk drug manufacturers are struggling financially," says Ajit Mahadevan, Partner - Life Sciences, Ernst & Young. "A lot of them are looking for funds and finding it difficult to manage them in these times." It may be a while before they are strong enough to fend off the dragon.
Article is located here.
It's a no-brainer that buying from a Chinese supplier is cheaper than from a Japanese one, right? Pravin Herlekar, Chairman of Omkar Speciality Chemicals, a Rs 100-crore bulk drug maker based in Badlapur, near Mumbai, learned the hard way that it is not always true. His company dumped its Japanese supplier of selenium when it found a cheaper source in China. But, Herlekar says, the Chinese suppliers resisted inspection of shipments before delivery. Within a few months, the intermediates that Omkar made using Chinese selenium began to suffer from quality issues. The company went back to sourcing selenium from Japan.
"Chinese suppliers often don't agree to third party inspections which help keep a check on quality," says Herlekar. Selenium derivatives are used to make an active pharmaceutical ingredient (API) or bulk drug. Bulk drugs are used to make medicines. For instance, intermediate compounds such as isobutyl benzene, aluminium chloride and sodium dichromate are used to make ibuprofen, the principal ingredient in formulation brands such as Combiflam.
With strong advantages such as economies of scale and government funding, Chinese companies have been flexing their muscles by resisting inspections, neglecting quality issues and raising prices. Many Indian companies are finding or creating alternatives to Chinese suppliers"
Lower prices offered by Chinese companies have caught the attention of many Indian drug makers. "In the last five years, API imports by Indian companies have doubled. In 2010/11, imports crossed $7 billion, of which China has a 60 per cent share," says O.R.S. Rao, Director, Cygnus Business Consulting and Research. "In the same period, India's bulk drug production has fallen to 35 per cent of its consumption, from about 70 per cent." The Hyderabad-based research firm releases a study on the Indian bulk drug industry every two years; the last edition was published in 2011. The Indian bulk drug market is valued at $13.5 billion, and its Chinese counterpart at $30 billion.
China and India are the leading players in bulk drugs, accounting for more than 40 percent of global bulk drug production. China is the largest bulk drug supplier, and India is second. Part of China's competitive advantage comes from the operating environment (lower interest rates, access to power and other infrastructure) and government aid (cheaper land, government funding). This has enabled Chinese manufacturers to benefit from economies of scale. China is also better endowed with raw materials such as phosphorous, potassium and sulphur. So it can produce bulk drugs at 10 percent of the cost in developed countries.
In 2010/11, bulk drug imports by Indian companies crossed dollar 7 billion, of which China has a 60 per cent share: O.R.S. RaoGiven their strong advantages, Chinese companies have been flexing their muscles by not allowing inspections, neglecting quality issues and raising prices. And Indian pharma seems to have finally decided that it needs to stop depending on China. Some Indian companies are integrating their operations backward to increase control over bulk drugs and intermediates. And, as price increases by Chinese manufacturers squeeze margins, Indian companies are trying to move up the value chain into the high-margin formulations business. Dependence on China has generated enough concerns for the Indian Drug Manufacturers' Association (IDMA) to call for anti-dumping duties on some bulk drugs and intermediates from China. IDMA also wants the government to set up a $700-million fund for bulk drug manufacturers. "Low-priced Chinese APIs are attractive, but this phenomenon can only be temporary," says Manish Doshi, President, IDMA.
"Nothing can stop them from raising prices once they know that Indian API manufacturers have closed down due to cut-throat competition. It is the government's duty to protect the industry from such dumping tactics by China." Doshi is also Managing Director at Amoli Organics and Umedica Laboratories, companies which were set up by his father and which make intermediates, bulk drugs and finished drugs. Naresh Gupta, who heads Lupin Laboratories's bulk drug unit, also argues that the government should try to level the playing field for Indian manufacturers. Incidentally, Lupin is the only Indian pharma major that exports bulk drugs to China.
Omkar Speciality Chemicals isn't waiting for the government act, however. Its strategy is to meet international standards. Its Badlapur factory has good manufacturing practices (GMP) status from the US Food and Drugs Administration. Regulatory authorities in many countries grant GMP status, but the most important for Indian companies are the US and British authorities, besides Indian regulators. Omkar will also seek GMP status for its factory coming up in Chiplun, Maharashtra. Herlekar says his advantage will be quality. "Indian formulations majors are increasingly sourcing from India, as they don't have to maintain large stocks and quality can be controlled," he says. "Most Indian API and intermediates manufacturers get their facilities audited by their customers, so quality isn't much of an issue."
Another strategy is backward integration. Shasun Chemicals and drugs, a Chennai-based Rs 1,000-crore company, has decided to manufacture some intermediates at its Andhra Pradesh plant, rather than importing them from China. Managing Director S. Abhaya Kumar says: "We have earmarked Rs 70 crore to move production of some of our key intermediates to India. The shift should be complete by December." He adds that intermediate prices in China have increased by 10 per cent in the last three months, because of rising petroleum prices and pressure on China to adhere to environmental norms. Shasun is the largest producer of ibuprofen in the world. It is developing 13 APIs for a few billion-dollar drugs whose patents expire in the next five years.
Another way to integrate backward is to acquire a bulk drug maker. For example, Mumbai-based Aanjaneya Lifecare bought intermediates manufacturer Apex Drugs in February for Rs 250 crore. The aim is to reduce dependence on third parties and reduce its vulnerability to fluctuations in price and supply. Similarly, Indoco Remedies, also based in Mumbai, acquired bulk drug maker La Nova Chem in 2006. The contribution of bulk drugs to overall revenues is negligible, but Indoco plans capital expenditure of Rs 55 crore over the next couple of years in its bulk drug factory at Patalganga, near Mumbai.
To counter the Chinese, big Indian drug makers such as Dr. Reddy's, Ranbaxy and Lupin have been moving up the value chain, from intermediates and bulk drugs to generics. But not everyone finds it easy to walk away from China.
"Only intermediates that have an impact on the quality of the finished product are manufactured in India or inhouse," says Sanjay Bhanushali, Head of International Business at Cipla. Procurement from China has increased five to eight per cent every year for the last three years." Cipla is looking at stronger alliances with other Indian or overseas companies to avoid sudden shocks. It is also open to dealing with companies in other markets, such as Brazil, Argentina, and Vietnam.
Lupin's Gupta says his company's Japanese operations are looking to shift all bulk drug manufacturing to India. "Despite price volatility in some inputs, the company was able to insulate itself due to hedging," he adds. Quality and research differentiate India from China. India has more than 175 plants approved by the US FDA - the highest number outside the US. Focus on quality has helped Indian companies increase their presence in developed markets. According to a report published in April by HSBC Global Research, half the Drug Master Files (DMF) in the first three months of this year are from Indian companies, compared to China's share of 14 per cent. DMF documents contain complete information about a drug's chemistry and manufacturing process, among other things, and enable a company to protect its intellectual property.
Many medium-sized bulk drug manufacturers have, with investments in research and development, shifted focus to late-stage intermediates and complex synthetic APIs. Chandigarh-based Parabolic Drugs , a Rs 900-crore company, recently commissioned a facility to manufacture bulk drugs in new therapy areas such as oncology and lifestyle ailments such as diabetes. The facility is likely to generate revenues of Rs 50 crore to Rs 75 crore in the current financial year and when fully operational, can generate up to Rs 300 crore.
But in the near future, it looks as if Chinese companies will continue to bleed Indian bulk drug makers. The capital-intensive nature of operations and extended working capital cycles have suppressed their return on capital. "Many bulk drug manufacturers are struggling financially," says Ajit Mahadevan, Partner - Life Sciences, Ernst & Young. "A lot of them are looking for funds and finding it difficult to manage them in these times." It may be a while before they are strong enough to fend off the dragon.
Article is located here.
CPPA Seeks Comments on Draft Standards for Community Pharmacy Practice Accreditation
July 05, 2012 03:15 PM
The Center for Pharmacy Practice Accreditation (CPPA) seeks review and comment on the newly released draft standards for community pharmacy practice accreditation. The draft standards will serve as the basis for community pharmacy practice accreditation. They are designed to facilitate the delivery of quality pharmacy services to patients, as well as recognize and stimulate innovative community pharmacy practices.
“Input from pharmacists, health care system stakeholders, consumer groups and patients – the ultimate recipients of pharmacist services – is vitally important to the establishment of consensus standards for community pharmacy practice accreditation,” stated Thomas E. Menighan, BSPharm, ScD, MBA, CPPA President and chair of the CPPA Board of Directors. “The draft standards being released today are the product of months of consideration by a broad group of stakeholders. Yet, this draft is only a start. Ultimately the standards and process will be as good as the input we receive. Well developed and implemented standards can create the specificity, measurability and predictability that are required for broad adoption of pharmacists’ services as the norm in health care.”
CPPA is a partnership between the American Pharmacists Association and the NABP. CPPA develops and implements comprehensive programs of pharmacy practice site accreditation, including the promotion, development, and maintenance of principles, policies, and standards. CPPA offers the general public and users of pharmacy services a means of identifying those pharmacies that satisfy the accreditation criteria and are focused on advancing patient care, safety, and quality.
Public participation in the review of these standards is important. To review the draft standards and submit comments, visit http://cppa.pharmacist.com. The deadline for submissions is August 15, 2012. The full news release is available on the American Pharmacists Association Web site.
Post can be found here.
“Input from pharmacists, health care system stakeholders, consumer groups and patients – the ultimate recipients of pharmacist services – is vitally important to the establishment of consensus standards for community pharmacy practice accreditation,” stated Thomas E. Menighan, BSPharm, ScD, MBA, CPPA President and chair of the CPPA Board of Directors. “The draft standards being released today are the product of months of consideration by a broad group of stakeholders. Yet, this draft is only a start. Ultimately the standards and process will be as good as the input we receive. Well developed and implemented standards can create the specificity, measurability and predictability that are required for broad adoption of pharmacists’ services as the norm in health care.”
CPPA is a partnership between the American Pharmacists Association and the NABP. CPPA develops and implements comprehensive programs of pharmacy practice site accreditation, including the promotion, development, and maintenance of principles, policies, and standards. CPPA offers the general public and users of pharmacy services a means of identifying those pharmacies that satisfy the accreditation criteria and are focused on advancing patient care, safety, and quality.
Public participation in the review of these standards is important. To review the draft standards and submit comments, visit http://cppa.pharmacist.com. The deadline for submissions is August 15, 2012. The full news release is available on the American Pharmacists Association Web site.
Post can be found here.
Federal Investigation Takes Down New Breed of Pill Mills in Florida
DEA Press Release
June 27 – (Vero Beach, FL) – Seven doctors and seven clinic owners, which included two firemen were charged on state racketeering violations spanning across Florida. This morning’s operation dubbed “Operation Pill Street Blues” was announced by Mark R. Trouville, Special Agent in Charge of the Drug Enforcement Administration, Miami Field Division; Pam Bondi, Attorney General of Florida, Deryl Loar, Sheriff, Indian River County Sheriff’s Office; David Currey, Chief, Vero Beach Police Department, and Dr. John H. Armstrong, Surgeon General, Department of Health. The arrests come following a two year investigation led by the DEA in conjunction with the Indian River County Sheriff’s Office, Vero Beach Police Department, and the Attorney General’s Office of Statewide Prosecution.
The defendants charged are: Lewis Gabriel Stouffer (32/Coconut Creek), Craig Louis Turturo (32/Boca Raton), Bruce Paul Karlin (63/Delray Beach), Courtland Burr Twyman (38/Deerfield Beach), Jeffrey Clark Thompson (32/Pompano Beach), Dale Andrew Gatlin (59/Jacksonville), Jeffrey J. Reiter (54/Fort Pierce), Dr. Bruce Jay Kammerman (54/Palm City), Dr. Susan Helen Yandle (48/Jacksonville), Dr. Fernando Valle (58/Orlando), Dr. Roger Lee Gordon (65/Plantation), Dr. Joseph Patrick Buffalino (64/Sarasota), Dr. Sanjay Trivedi (49/St. Johns), Dr. Michael Charles Bengala (67/Pompano Beach).
These defendants are facing 144 violations of Florida statutes which include the following offenses: racketeering; conspiracy to commit racketeering; manslaughter; trafficking in a controlled substance; conspiracy to traffic in a controlled substance (28 grams or more); delivery of a controlled substance; illegally prescribing a controlled substance by a practitioner; illegally prescribing a controlled substance (oxycodone hydrochloride) by a practitioner-trafficking amount; workers compensation fraud; and money laundering.
Today’s operation resulted in the arrest of 12 defendants. Bruce Karlin and Courtland Twyman are expected to surrender within 24 hours. In addition, approximately 59 bank accounts were seized totaling approximately $1.1 million, and 13 search warrants have been executed in nine jurisdictions including seven search warrants on clinics at the following locations:
Stuart Pain Management, 1146 21st Street; Vero Beach, Southern Back & Spine, 424 N. Peninsula Drive, Daytona Beach; Jacksonville Back & Spine, 1845 University Blvd., N Jacksonville; Gainesville Health & Wellness, 7731 W Newberry Road, Gainesville; Sarasota Pain Management, 5580 Bee Ridge Road, Sarasota; Miami Dade Medical Solutions; 1021 Ives Dairy Road, Miami; and Sunset Pharmacy (AIW) 4224 Cleveland Avenue, Fort Myers.
This investigation began in May 2010 when law enforcement responded to numerous community concerns regarding suspicious activities at the Stuart Pain Management in Vero Beach, Florida. During the investigation, agents traced Stuart Pain Management and eight other clinics, which spanned from Pensacola to Miami, Florida, to an organization headed by Lewis Stouffer. During the investigation, agents also learned that Stouffer and his partner Craig Turturo are active Pompano Beach Firemen.
The investigation further revealed Stouffer used his business sense to research public records relating to past DEA investigations such as Operation Pill Nation and Operation Oxy Alley in order to avoid law enforcement scrutiny. Stouffer used his hero firefighter/paramedic image, to maneuver through the system. Stouffer maintained a rapport with local law enforcement. He educated his co-conspirators on how to successfully report their competition as well as how to report doctor shoppers in order to appear as though they were legitimate pain clinics. All the while, Stouffer was receiving a “tribute” or percentage of the clinic’s income for his services as “the brains of the operation.” While Stouffer’s efforts give the resemblance of legitimacy, his drug enterprise had just one purpose: to make money from illegal drug trafficking and the financing of illegal drug trafficking throughout Florida.
The Stouffer drug trafficking organization is responsible for diversion of millions of narcotic medications, including Oxycodone, Roxicodone, Percocet, Xanax, MS Contin, and Valium throughout Florida. Doctors were recruited by the Stouffer organization to prescribe the medically unnecessary narcotics to doctor shoppers. Many of their “patients” were addicts and abused the prescriptions while others sold the drugs on the street for profit. As a result, Stouffer and his partners have made millions of dollars from the operation of their illegal drug network.
The investigation involved the use of judicial wire intercepts, informants, and under cover visits to clinics that spanned from Pensacola to Miami, Florida. The undercover agents visited each of the seven doctors charged and were prescribed approximately 2,732 oxycodone tablets without medical justification.
Between July 2011 and June 2012, conversations were judicially intercepted between the members of this drug trafficking organization. The calls revealed how Stouffer would instruct his pain clinic managers on how to detect undercover agents, and how they refer to some of their doctors as “serial killers” and referred to their patients as “junkies.” Karlin and Gatlin joked about a doctor, who worked at Stuart Pain Management, being “high on drugs” and being “a prescription addict like our patients.” The calls revealed they had no remorse for their patients’ deaths. For example, on or about March 8, 2012, Karlin called Stouffer to tell him about the death of Forrest Cyphers, a patient of Dr. Gordon at Stuart Pain Management. During the call, Stouffer told him not to worry as “people die every day.” Dr. Gordon and Karlin are being charged with Manslaughter for the death of Forrest Cyphers.
The seven doctors charged are responsible for dispensing over two million Oxycodone 30 milligram tablets within a single year. Each doctor will be served an Immediate Suspension Orders (ISO) by the DEA, which suspends their ability to prescribe, dispense, and administer any controlled substance. The table below is a breakdown of the number of Oxycodone 30 milligram tablets that were prescribed by the doctors in the Stouffer organization.
Prescribing Doctors
Quantity
Bruce Kammerman
644,266
SusanYandle
506,184 (9 mos)
Fernando Valle
430,899
Roger Gordon
271,140
Michael Bengala
126,808 (4 mos)
Sanjay Trivedi
98,822
Joseph Buffalino
67,084 (7 mos)
Total
2,145,203
This investigation is ongoing. Additional arrests of co-conspirators are forthcoming, to include doctors and others.
SAC Trouville commended the Department of Health on their assistance in this investigation relating to Emergency Suspension Orders of medical and business licenses for these rouge doctors and pain clinics.
This investigation was conducted by the DEA, Indian River County Sheriff’s Office and Vero Beach Police Department, with assistance from the Attorney General’s Civil and Medicaid Fraud Divisions, the Agency for Health Care Administration, Alachua County Sheriff’s Office, Broward County Sheriff’s Office, Daytona Beach Police Department, Escambia County Sheriff’s Office, Florida Department of Financial Services, Florida Department of Health, Florida Department of Law Enforcement, Florida Division of Insurance Fraud, Ft. Pierce Police Department, Gainesville Police Department, Highlands County Sheriff’s Office, Hillsborough County Sheriff’s Office, Internal Revenue Service, Jacksonville Sheriff’s Office, Manatee County Sheriff’s Office, Miami-Dade Police Department, Palm Beach County Sheriff’s Office, Port St. Lucie Police Department, Sarasota County Sheriff’s Office, Sebastian Police Department, Tampa Police Department, Volusia County Sheriff’s Office, and North Florida High Intensity Drug Trafficking Area.
This investigation is being prosecuted by the Attorney General’s Office of Statewide Prosecution and the State Attorney’s Office 19 th Judicial Circuit.
The charging document is merely an accusation and the defendants are assumed innocent unless and until proven guilty.
June 27 – (Vero Beach, FL) – Seven doctors and seven clinic owners, which included two firemen were charged on state racketeering violations spanning across Florida. This morning’s operation dubbed “Operation Pill Street Blues” was announced by Mark R. Trouville, Special Agent in Charge of the Drug Enforcement Administration, Miami Field Division; Pam Bondi, Attorney General of Florida, Deryl Loar, Sheriff, Indian River County Sheriff’s Office; David Currey, Chief, Vero Beach Police Department, and Dr. John H. Armstrong, Surgeon General, Department of Health. The arrests come following a two year investigation led by the DEA in conjunction with the Indian River County Sheriff’s Office, Vero Beach Police Department, and the Attorney General’s Office of Statewide Prosecution.
The defendants charged are: Lewis Gabriel Stouffer (32/Coconut Creek), Craig Louis Turturo (32/Boca Raton), Bruce Paul Karlin (63/Delray Beach), Courtland Burr Twyman (38/Deerfield Beach), Jeffrey Clark Thompson (32/Pompano Beach), Dale Andrew Gatlin (59/Jacksonville), Jeffrey J. Reiter (54/Fort Pierce), Dr. Bruce Jay Kammerman (54/Palm City), Dr. Susan Helen Yandle (48/Jacksonville), Dr. Fernando Valle (58/Orlando), Dr. Roger Lee Gordon (65/Plantation), Dr. Joseph Patrick Buffalino (64/Sarasota), Dr. Sanjay Trivedi (49/St. Johns), Dr. Michael Charles Bengala (67/Pompano Beach).
These defendants are facing 144 violations of Florida statutes which include the following offenses: racketeering; conspiracy to commit racketeering; manslaughter; trafficking in a controlled substance; conspiracy to traffic in a controlled substance (28 grams or more); delivery of a controlled substance; illegally prescribing a controlled substance by a practitioner; illegally prescribing a controlled substance (oxycodone hydrochloride) by a practitioner-trafficking amount; workers compensation fraud; and money laundering.
Today’s operation resulted in the arrest of 12 defendants. Bruce Karlin and Courtland Twyman are expected to surrender within 24 hours. In addition, approximately 59 bank accounts were seized totaling approximately $1.1 million, and 13 search warrants have been executed in nine jurisdictions including seven search warrants on clinics at the following locations:
Stuart Pain Management, 1146 21st Street; Vero Beach, Southern Back & Spine, 424 N. Peninsula Drive, Daytona Beach; Jacksonville Back & Spine, 1845 University Blvd., N Jacksonville; Gainesville Health & Wellness, 7731 W Newberry Road, Gainesville; Sarasota Pain Management, 5580 Bee Ridge Road, Sarasota; Miami Dade Medical Solutions; 1021 Ives Dairy Road, Miami; and Sunset Pharmacy (AIW) 4224 Cleveland Avenue, Fort Myers.
This investigation began in May 2010 when law enforcement responded to numerous community concerns regarding suspicious activities at the Stuart Pain Management in Vero Beach, Florida. During the investigation, agents traced Stuart Pain Management and eight other clinics, which spanned from Pensacola to Miami, Florida, to an organization headed by Lewis Stouffer. During the investigation, agents also learned that Stouffer and his partner Craig Turturo are active Pompano Beach Firemen.
The investigation further revealed Stouffer used his business sense to research public records relating to past DEA investigations such as Operation Pill Nation and Operation Oxy Alley in order to avoid law enforcement scrutiny. Stouffer used his hero firefighter/paramedic image, to maneuver through the system. Stouffer maintained a rapport with local law enforcement. He educated his co-conspirators on how to successfully report their competition as well as how to report doctor shoppers in order to appear as though they were legitimate pain clinics. All the while, Stouffer was receiving a “tribute” or percentage of the clinic’s income for his services as “the brains of the operation.” While Stouffer’s efforts give the resemblance of legitimacy, his drug enterprise had just one purpose: to make money from illegal drug trafficking and the financing of illegal drug trafficking throughout Florida.
The Stouffer drug trafficking organization is responsible for diversion of millions of narcotic medications, including Oxycodone, Roxicodone, Percocet, Xanax, MS Contin, and Valium throughout Florida. Doctors were recruited by the Stouffer organization to prescribe the medically unnecessary narcotics to doctor shoppers. Many of their “patients” were addicts and abused the prescriptions while others sold the drugs on the street for profit. As a result, Stouffer and his partners have made millions of dollars from the operation of their illegal drug network.
The investigation involved the use of judicial wire intercepts, informants, and under cover visits to clinics that spanned from Pensacola to Miami, Florida. The undercover agents visited each of the seven doctors charged and were prescribed approximately 2,732 oxycodone tablets without medical justification.
Between July 2011 and June 2012, conversations were judicially intercepted between the members of this drug trafficking organization. The calls revealed how Stouffer would instruct his pain clinic managers on how to detect undercover agents, and how they refer to some of their doctors as “serial killers” and referred to their patients as “junkies.” Karlin and Gatlin joked about a doctor, who worked at Stuart Pain Management, being “high on drugs” and being “a prescription addict like our patients.” The calls revealed they had no remorse for their patients’ deaths. For example, on or about March 8, 2012, Karlin called Stouffer to tell him about the death of Forrest Cyphers, a patient of Dr. Gordon at Stuart Pain Management. During the call, Stouffer told him not to worry as “people die every day.” Dr. Gordon and Karlin are being charged with Manslaughter for the death of Forrest Cyphers.
The seven doctors charged are responsible for dispensing over two million Oxycodone 30 milligram tablets within a single year. Each doctor will be served an Immediate Suspension Orders (ISO) by the DEA, which suspends their ability to prescribe, dispense, and administer any controlled substance. The table below is a breakdown of the number of Oxycodone 30 milligram tablets that were prescribed by the doctors in the Stouffer organization.
Prescribing Doctors
Quantity
Bruce Kammerman
644,266
SusanYandle
506,184 (9 mos)
Fernando Valle
430,899
Roger Gordon
271,140
Michael Bengala
126,808 (4 mos)
Sanjay Trivedi
98,822
Joseph Buffalino
67,084 (7 mos)
Total
2,145,203
This investigation is ongoing. Additional arrests of co-conspirators are forthcoming, to include doctors and others.
SAC Trouville commended the Department of Health on their assistance in this investigation relating to Emergency Suspension Orders of medical and business licenses for these rouge doctors and pain clinics.
This investigation was conducted by the DEA, Indian River County Sheriff’s Office and Vero Beach Police Department, with assistance from the Attorney General’s Civil and Medicaid Fraud Divisions, the Agency for Health Care Administration, Alachua County Sheriff’s Office, Broward County Sheriff’s Office, Daytona Beach Police Department, Escambia County Sheriff’s Office, Florida Department of Financial Services, Florida Department of Health, Florida Department of Law Enforcement, Florida Division of Insurance Fraud, Ft. Pierce Police Department, Gainesville Police Department, Highlands County Sheriff’s Office, Hillsborough County Sheriff’s Office, Internal Revenue Service, Jacksonville Sheriff’s Office, Manatee County Sheriff’s Office, Miami-Dade Police Department, Palm Beach County Sheriff’s Office, Port St. Lucie Police Department, Sarasota County Sheriff’s Office, Sebastian Police Department, Tampa Police Department, Volusia County Sheriff’s Office, and North Florida High Intensity Drug Trafficking Area.
This investigation is being prosecuted by the Attorney General’s Office of Statewide Prosecution and the State Attorney’s Office 19 th Judicial Circuit.
The charging document is merely an accusation and the defendants are assumed innocent unless and until proven guilty.
Federal Pill Mill Investigation Results in Multiple Arrests in Florida
The National Association of Boards of Pharmacy is reporting:
A multi-agency operation has resulted in charges against seven doctors and seven clinic owners on state racketeering violations related to the operation of illegal pain clinics throughout Florida. Drug Enforcement Administration (DEA) reports that the defendants “face 144 violations of Florida statutes which include the following offenses: racketeering; conspiracy to commit racketeering; manslaughter; trafficking in a controlled substance; conspiracy to traffic in a controlled substance (28 grams or more); delivery of a controlled substance; illegally prescribing a controlled substance by a practitioner; illegally prescribing a controlled substance (oxycodone hydrochloride) by a practitioner-trafficking amount; workers compensation fraud; and money laundering.” As of June 27, 2012, 12 of the defendants had been arrested, and approximately 59 bank accounts were seized totaling approximately $1.1 million. Further, DEA notes that 13 search warrants have been executed in nine jurisdictions including search warrants on clinics.
Numerous community concerns regarding suspicious activities at the Stuart Pain Management, Vero Beach, FL, initiated an investigation in May 2012. Agents discovered that Stuart Pain Management and eight other clinics throughout Florida were operated by an organization headed by Lewis Stouffer. Stouffer and his partner Craig Turturo are active Pompano Beach firemen. According to DEA, “Stouffer used his hero firefighter/paramedic image, to maneuver through the system. Stouffer maintained a rapport with local law enforcement. He educated his co-conspirators on how to successfully report their competition as well as how to report doctor shoppers in order to appear as though they were legitimate pain clinics. . . The Stouffer drug trafficking organization is responsible for diversion of millions of narcotic medications, including Oxycodone, Roxicodone, Percocet, Xanax, MS Contin, and Valium throughout Florida.”
Additional details about the investigation and charges are available in a DEA news release. This investigation is ongoing and is being prosecuted by the Attorney General’s Office of Statewide Prosecution and the State Attorney’s Office 19th Judicial Circuit. DEA notes that the charging document is merely an accusation and the defendants are assumed innocent unless and until proven guilty.
This article can be found here.
Additional details about the investigation and charges are available in a DEA news release. This investigation is ongoing and is being prosecuted by the Attorney General’s Office of Statewide Prosecution and the State Attorney’s Office 19th Judicial Circuit. DEA notes that the charging document is merely an accusation and the defendants are assumed innocent unless and until proven guilty.
This article can be found here.
K-V sues FDA over Makena in fight for survival
Thu Jul 5, 2012 6:59pm EDT
* Focus on cheaper versions of preterm birth drug Makena * K-V says FDA favored cost over science, safety* Says will go bankrupt in 3-6 months without FDA action
* FDA has said compounded versions pose no risk
By Anna Yukhananov
WASHINGTON, July 5 (Reuters) - K-V Pharmaceutical Co is suing the U.S. Food and Drug Administration for not cracking down on compounded versions of its premature birth drug Makena, in a last-ditch fight for the company's survival.
Makena is an injectable hormonal medicine that reduces the risk of pre-term birth in women who have already delivered early in the past. K-V got approval to sell Makena last year, giving it a new lease on life after it was barred from making and marketing its own drugs due to repeated manufacturing problems.
But pharmacies had already been compounding a similar, and far cheaper, drug for years for people who had a prescription from a doctor. They use the active ingredient hydroxyprogesterone that has been available on the market without formal FDA clearance.
In its lawsuit, K-V said the FDA was addressing the financial concerns of insurance companies that cover the cost of medications instead of the needs of patients in declining to stop pharmacies from making cheaper versions of the Makena drug. By law, the FDA is only allowed to make decisions based on science, not cost.
K-V said Makena's sales are not enough for the company to satisfy its creditors, and it would go bankrupt within three to six months if the FDA failed to act, according to the lawsuit filed on Thursday in the U.S. District Court for the District of Columbia.
FDA spokeswoman Sarah Clark-Lynn said the agency does not comment on pending litigation.
Shares of K-V closed up 2.2 percent at 65 cents on the New York Stock Exchange, above the 45 cents it hit last week, but still a fraction of its value of over $3 a year ago.
FDA DILEMMA
The FDA normally issues warning letters to distributors of unapproved drugs, or may seize their products.
The FDA recently launched a drive to remove all unapproved drugs from the market due to safety issues, and encouraged companies to apply for formal clearance, but has not taken a hard line against the pre-term birth medications.
Patients and insurers preferred the pharmacy compounds, which cost $10 to $20 per injection versus the $1,500 K-V initially sought to charge for Makena after it was approved in February 2011.
K-V reportedly tried to stop pharmacies from compounding the drug by sending them letters saying they were violating the law and threatening to sue them.
But the FDA said it would take no action against pharmacies that offered the cheaper product, following complaints from U.S. lawmakers and health insurers that K-V was price-gouging for a drug already available on the market. K-V then slashed the price of Makena by 55 percent to $690.
K-V still argued that the older pharmacy compounds were not as safe or effective as Makena, as pharmacies don't need to meet the same manufacturing, safety and efficacy guidelines.
The FDA agreed in November to look into the issue, inspecting 16 samples of the compounded drug and of its active ingredient. In an announcement last month, the health regulator said these versions of Makena posed no major safety risks, though they contained some impurities.
"Although the analysis of this limited sample ... did not identify any major safety problems, approved drug products, such as Makena, provide a greater assurance of safety and effectiveness than do compounded products," it said at the time.
The agency also said it was applying its "normal enforcement policies" in declining to stop the compounding pharmacies from making Makena, as it focuses its actions on products that are fraudulent or likely to cause harm.
The case is K-V Pharmaceutical Company v. FDA, U.S. District Court, District of Columbia, No. 12-01105.
New Article can be found here.
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