press release

July 2, 2012, 11:48 a.m. EDT

GlaxoSmithKline's (GSK) $3 Billion Whistleblower Settlement Has Paid for One Of America's Most Expensive Failed Corporate Internal Investigations, Qui Tam Whistleblowers' Attorneys Say

PHILADELPHIA, July 2, 2012 /PRNewswire via COMTEX/ -- GlaxoSmithKline has just paid for one of the most expensive failed internal investigations in corporate history, qui tam whistleblower attorney Brian Kenney said today. His law firm, Kenny & McCafferty, P.C., represents the two whistleblowers who sparked the nine-year federal probe that ended with today's $3 billion payment to settle off-label drug marketing allegations involving nine prescription drugs.
"When our clients were forced out of their marketing positions, GlaxoSmithKline ('GSK') had proof of illegal off-label prescription drug marketing. Our clients properly reported those marketing misdeeds to management in 2001. An ensuing GSK internal investigation verified their allegations, but the company took no action, choosing hefty profits over compliance and patient safety," said whistleblower attorney Tavy Deming of Kenney & McCafferty.
"GSK could have saved hundreds of millions, perhaps a billion or more dollars of the $3 billion it paid today by following through on the combined Human Resources /Corporate Compliance investigation they launched. Instead they ignored evidence of improper marketing and physician kickbacks. When you look at the detail and accuracy of Greg Thorpe's written complaints distributed to the highest levels of Glaxo (See 'Document Links' Below) it's almost surreal that the company took no corrective action. Now more than a decade later, GSK is essentially admitting that Thorpe had been right in 2001," Kenney said. "It's been a very, very, very long 10 years for whistleblowers Thorpe and Blair Hamrick."
GSK's top management was aware of illegal marketing schemes involving the drugs, according to filed court documents. When the two Kenney & McCafferty-represented whistleblowers reported their concerns about illegal marketing practices they were witnessing in the field, GSK's top compliance executive, an attorney who now holds a similar position with another medical device manufacturer, became involved in and oversaw the ensuing internal investigation.
Instead of changing the illegal conduct, the Company retaliated against the whistleblowers and they became the first to file an off-label marketing qui tam whistleblower Complaint against GSK. The original Complaint is one of the first ever filed alleging prescription drug off-label promotion, Kenney said.
When the whistleblowers' Complaints were still under seal and being investigated by the government GSK allegedly falsified and concealed documents in connection with an FDA inquiry into whether GSK marketed the antidepressant drug Wellbutrin off-label for weight loss, a central allegation in the whistleblowers' Complaints. That led to the indictment of a GSK associate corporate counsel, said Deming. Federal charges against the former associate general counsel later were subsequently dismissed by the court. (U.S. v. Lauren Stevens, District of Maryland)
Thorpe and Hamrick provided first-hand revelations of GSK's pervasive marketing misconduct relating to the nine drugs identified in Kenney & McCafferty's Complaint (See "Document Links" Below) and Exhibits (See "Document Links" Below) unsealed with today's settlement. According to Emily Lambert of Kenney & McCafferty, the Government joined the whistleblowers' case and filed a Complaint-in-Intervention adopting the whistleblower's claims. (See "Document Links" Below)
Extremely persuasive proof exposing illegal marketing of the asthma drug Advair for mild asthma was included in the insider evidence that Thorpe and Hamrick provided to Government investigators, Deming said. GSK's mild asthma marketing campaign contravened Advair's approved asthma use, which was limited to moderate and severe forms of asthma, and a black box warning on the drug's label, yet GSK's marketing efforts continued unabated into 2010. As a result, Advair's portion of taxpayers' recovery represents nearly 70 percent of the Government's total $1.017 billion civil settlement of our clients' claims, Lambert added.
The nine prescription drugs covered by the settlement included Advair, Wellbutrin, Paxil, Lamictal, Zofran, Imitrex, Lotronex, Flovent and Valtrex.
GSK maintained an elaborate illegal marketing regime for the prescription drugs included in today's settlement, including, according to filed documents:
Paying physicians (who could be counted on to influence their peers) as much as $25,000 for being a GSK "advisory board" member;
Enrolling 49,000 physicians and health professionals to be part of its speakers bureau;
Identifying physicians in academia to pay to speak on behalf of one of the company's drugs;
Creating the PowerPoint "slide kits" that physicians would use to deliver canned presentations;
Using an elaborate "FaxBack" system allowing drug marketing reps to suggest articles related to off-label uses. The physicians would order these -off-label promotional materials by calling a toll-free number, and thus not appear to be responding to an illegal marketing effort by the drug marketing representative;
Pushing Imitrex, an adult medicine for migraine, for mild headaches, as well as for use in children, despite the FDA's rejection of GSK's application for child use due to lack of efficacy;
Pushing Lamictal, a drug approved only for partial seizures, in adults for other diagnoses. In at least one case a patient died from a reaction that the company had evidence could occur;
Marketing Paxil, the antidepressant, to children under 18 when it had not been approved for youngsters, and despite GSK's own clinical trails that had shown that the drug was ineffective for children and also heightened the risk of suicide or other self-harming behavior three-fold; and,
Marketing the antidepressant Wellbutrin as superior to other antidepressant alternatives due to increased sexual functioning and weight loss, pushing the drug as the "happy, horny, skinny drug," to concisely encapsulate GSK's off-label Wellbutrin marketing campaign.
Physicians are free to prescribe drugs for off-label uses, but pharmaceutical companies are prohibited from marketing the drugs for uses that have not been approved by the FDA. Federal laws also prohibit pharmaceutical companies from paying kickbacks to physicians to induce prescriptions. Generally, government-funded healthcare programs such as Medicare and Medicaid preclude reimbursement for off-label prescriptions. When a pharmaceutical company's illegal marketing practices cause off-label prescriptions to be written by doctors, and those prescriptions are paid for by Medicare and Medicaid, the payment becomes an actionable False Claims Act ("FCA") violation, according to Kenney, who is a former federal prosecutor.
Under the FCA, qui tam actions allow private citizens with knowledge of fraud to help the Government recover ill-gotten gains and additional civil penalties. The FCA allows the Government to collect up to three times the amount it was defrauded, in addition to civil penalties from $5,500 to $11,000 per false claim.
In successful qui tam whistleblower cases in which the Government intervenes, whistleblowers are entitled to receive a percentage of qui tam recoveries, typically 15-to-25 percent, generally known as, "the relator's share."
Under the terms of the settlement agreement, the Government and the whistleblowers did not concede that their respective claims are not well founded. In turn, as is typical in civil agreements, GSK expressly denied liability, except for those admissions GSK agreed to make in connection with connection with a criminal Plea Agreement. Specifically, according to the agreement, GSK has agreed to plead guilty to criminal charges that the company misbranded Wellbutrin and Paxil and it failed to report data relating to clinical experience, along with other data and information regarding the diabetes drug Avandia to the Food and Drug Administration ("FDA") in mandatory reports, all in violation of the Food, Drug and Cosmetic Act ("FDCA").
In addition to paying a $1.042 billion civil settlement to the federal and state Governments, as part of the Settlement Agreement GSK agreed to be bound by a Corporate Integrity Agreement ("CIA") with the Office of Inspector General of the United States Department of Health and Human Services ("OIG-HHS").
The federal investigation into GSK's marketing practices was conducted through a collaborative effort of the U.S. Department of Justice, and the U.S. Attorney's Offices for the District of Massachusetts and the District of Colorado. Massachusetts Assistant Attorney General Bob Patten led the investigation on behalf of the states and the National Association of Medicaid Fraud Control Units ("NAMFCU").
Case Caption: United States ex rel. Thorpe, et al. v. GSK, et al.Civ. No.: 11-10398 (D.Mass) 

FDA prompts companies to remove certain unapproved oxycodone products from market

For Immediate Release: July 5, 2012 
Media Inquiries: Sarah Clark-Lynn 301-796-9110, sarah.clark-lynn@fda.hhs.gov 
Consumer Inquiries: 888-INFO-FDA 
The U.S. Food and Drug Administration today issued a Federal Register notice instructing companies to stop manufacturing and distributing certain unapproved drugs that contain oxycodone. The notice is part of the FDA’s Unapproved Drugs Initiative to remove unapproved new drugs from the market. The FDA action affects companies that manufacture and distribute unapproved single-ingredient, immediate-release oxycodone drug products in oral dosage forms, including tablets, capsules and oral solutions. These products have not been evaluated by the FDA for safety, effectiveness, manufacturing quality, or appropriate labeling, including dosing information and warnings, and cannot be legally marketed in the United States. Oxycodone is an opioid analgesic, a class of powerful pain medications. Oxycodone is listed under Schedule II of the Controlled Substances Act with an abuse liability similar to other opioid agonists. Improper labeling and use of oxycodone can lead to overdose and death. FDA recognizes that opioid medications are associated with prescription drug misuse, abuse, and addiction, which have resulted in an increase in injuries and deaths across the United States over the last 10 years. “It’s a high public health priority for FDA to remove these unapproved products from the market to minimize consumer exposure to drugs that may be unsafe, ineffective, and of poor quality,” said Ilisa Bernstein, acting director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “Since FDA-approved versions of these oral dosage forms are available by prescription, there should be no negative impact on consumers as a result of this action and no disruptions to the drug supply.” The FDA’s Unapproved Drugs Initiative, which began in June 2006, is the agency’s risk-based enforcement approach to efficiently and rationally bring all unapproved new drugs into the approval process. One of the goals of the initiative is to reduce consumer exposure to drugs that are not proven safe, effective, and of high quality. Companies with certain products that are subject to this action are expected to stop manufacturing the products within 45 days and stop shipping the products within 90 days. Products that are subject to these timeframes are products that: were introduced onto the market before Sept. 19, 2011, were listed in the FDA’s Drug Registration and Listing System before July 6, 2012, and were being commercially used or sold before July 6, 2012. Companies that continue to market products that fall within this scope of this Federal Register notice are subject to enforcement action including seizure, injunction, or other judicial or administrative proceeding. Consumers and health care professionals are encouraged to report adverse side effects or medication errors from the use of prescription drug products to the FDA’s MedWatch Adverse Event Reporting program at www.fda.gov/MedWatch or by calling 800-332-1088. The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. For more information: Questions and Answers for Consumers about FDA's Action Involving Unapproved Oxycodone Single-Ingredient, Immediate Release Drug Products for Oral Administration

Simplified Test Method for Compounded Sterile Drugs

James P. Cooper has  written an article on a Simplified Test Method for Compounded Sterile Drugs. To read the article, click here.

Bath Salts Compounds Are An Evolving Problem For DEA

This article is from NPR and can be found here.

June 30, 2012

One night a little more than two years ago, a 24-year-old man was rushed into the emergency room at Tulane University Medical Center in Louisiana. He was extremely agitated and hallucinating.
Dr. Corey Hebert figured the man was on drugs, probably PCP or a stimulant. But a few minutes later, the man became paranoid.
"He started doing some self-mutilating actions [and] was pulling out his eyebrows and eyelashes," Hebert tells weekends on All Things Considered host Laura Sullivan.

There's no legitimate use for these particular compounds that we know of.

- Arthur Berrier, Drug Enforcement Agency

Hebert then thought maybe the patient had taken methamphetamine, but his symptoms changed again. Even more surprising, a drug scan of the patient showed up clean. Hebert and his colleagues were puzzled.
After talking to the man's friends, Hebert learned he had taken a new drug that goes by the street name "bath salts."
In the months that followed, Hebert's emergency room became ground zero for bath salts patients. Every few days another patient arrived. Soon emergency rooms nationwide began seeing them, too.
The synthetic drug's popularity has been growing. National poison control centers had 304 calls about bath salts in 2010, nearly a third of them from Louisiana. Last year, there were more than 6,000 calls.
'We're Playing Whack-A-Mole'
The problem is that bath salts — which have nothing to do with the crystals you'd put in your tub — aren't one kind of drug or something you can test for and treat.
Unlike a drug like cocaine, which is made with a natural process, bath salts are made in a lab and constantly changing. The drug is designed specifically to skirt the law and test the bounds of new chemicals — with often deadly results.
"Cocaine is cocaine ... all the time, and it's always illegal," says Jill Head, a senior forensic chemist with the Drug Enforcement Agency. "But these products are continuously changing ... so what we see this week can be very different from what we're going to see a month from now."
This is a problem for police, prosecutors and the DEA, which is trying to track what the drugs are and where they come from.
Making matters worse, the compounds in the drugs aren't necessarily illegal. Because the components keep changing, drug makers can stay one step ahead of law enforcement. Even on a rush basis, it can take months to get a compound banned as a controlled substance. The DEA has gotten three compounds put on the list so far, but the agency's chemists have identified more than 60 in the past two years.
"Basically, we're playing whack-a-mole," says Arthur Berrier, a senior research chemist for the DEA. "They make one drug ... or one compound, and we smack it down, and the next week, something else pops up."
Now the scientists at a DEA lab in Northern Virginia are doing something unusual: They're making their own bath salts.
Berrier tells Sullivan that in order to fully identify a compound, scientists need what is called standard material, or an authenticated drug with a known structure.

Related NPR Stories

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"So typically what we would do is if we identify something in a bath salt material, we'd have to have a standard [to compare it to] to really identify it," he says.
The compounds scientists are finding are generally legal compounds not specifically controlled by the DEA, Berrier says. They show up in gas stations, pipe shops and all over the Internet as plant food, incense, hookah cleaner and, of course, bath salts.
Berrier says sometimes store owners know that what they're selling is really drugs, but sometimes they don't. The key for drug seekers is small packaging and the phrase "not for human consumption," which is supposed to hint at the opposite.
"[But] there's no legitimate use for these particular compounds that we know of," Berrier says.
Legal Difficulties
What DEA chemists are doing in beakers, bath salt makers are doing in vats. Officials believe many of those facilities are in China, India and Pakistan. Producers ship the drugs in bulk to the U.S., where officials suspect the final mixing and packaging is done.
To try to bring criminal cases against suppliers, sellers and users of what are essentially legal compounds, the DEA and prosecutors have had to reach way down into the annals of the nation's drug laws.
DEA lab director Jeff Comparin tells Sullivan that the challenge is that if a substance is not specifically listed in Title 21 of U.S. Code, which governs food and drugs, it can be classified as legal — but there's a loophole.
"Because of the nature of the structure, the way the chemicals are designed, the controlled-substances act also has a clause called the 'analog' part, where we can try these chemicals as if they were a controlled substance," Comparin says.
That means the agency can try to show the user or supplier intended to ingest or sell the product as a drug — usually through circumstantial evidence. Comparin says the DEA has successfully prosecuted some analog cases.
This trend of synthetic drugs is new and developing, Comparin says, and it's hard to say how long it will last.
"Who's to say what effect the ultimate control of these chemicals will have on their continued manufacture, importation and trafficking in the U.S.?" he says. "But as you can see right now, we just detect the new compounds and address the threat as best we can."
Just this week, Congress moved to ban more of the compounds the DEA's lab has identified. In the meantime, officials are hoping users will realize that if scientists in the nation's drug lab can't keep up with what drug manufacturers are making, users shouldn't be so sure what they're getting.

FDA Issues More Guidance About Makena®

In the form of Questions and Answers issued on June 29, 2012, the FDA recommends healthcare providers prescribe FDA-approved Makena (hydroxyprogesterone caproate injection) made by K-V  Pharmaceutical Company as the first-line for clinically-indicated patients. The FDA has not determined any other form of progesterone to be effective for this medical condition. The FDA also explained its enforcement policy towards compounded formulations of hydroxyprogesterone caproate. The FDA Questions and Answers state:

The FDA Questions and Answers are as follows: 

What is pharmacy compounding?

The FDA regards pharmacy compounding as the combining or altering of the ingredients of a drug by a licensed pharmacist to produce a drug tailored to an individual patient’s particular medical needs, based on a valid prescription from a licensed medical practitioner. For example, compounding may occur if a patient needs a medication to be produced without a dye or preservative due to an allergy, or needs a medication in a liquid or suppository form because the patient cannot swallow a pill.

Should health care professionals prescribe and patients take the FDA-approved drug product rather than the compounded product?

If there is an FDA-approved drug that is medically appropriate for a patient, the FDA-approved product should be prescribed and used. Makena was approved based on an affirmative showing of safety and efficacy. The company also demonstrated the ability to manufacture a quality product. The pre-market review process included a review of the company’s manufacturing information, such as the source of the API used in the manufacturing of the drug, proposed manufacturing processes, and the firm’s adherence to current good manufacturing practice.
Compounded drugs do not undergo the same premarket review and thus lack an FDA finding of safety and efficacy and lack an FDA finding of manufacturing quality. Therefore, when an FDA-approved drug is commercially available, the FDA recommends that practitioners prescribe the FDA-approved drug rather than a compounded drug unless the prescribing practitioner has determined that a compounded product is necessary for the particular patient and would provide a significant difference for the patient as compared to the FDA-approved commercially available drug product.

How will a patient know if she is receiving Makena or a compounded product?

A patient can ask her health care provider what product is being administered. A label will also be visible on the vial or syringe with information such as the patient name, prescription number, and name of the product. Typically, if the pharmacy dispenses the FDA-approved product, it will have the brand name “Makena” on the label.

Will the agency take any enforcement action against pharmacies compounding versions of hydroxyprogesterone caproate products?

The FDA may take enforcement action against compounding pharmacies if warranted. The FDA makes its enforcement decisions about compounded products on a case-by-case basis after considering the particular facts at issue. As we explained in the June 15, 2012, statement¹, the compounding of any drug, including hydroxyprogesterone caproate, should not exceed the scope of traditional pharmacy compounding.

Are pharmacies free to compound large volumes of hydroxyprogesterone caproate as long as none of their drugs are tested and found to be unsafe?

No. The FDA does not consider compounding large volumes of copies, or what are essentially copies, of any approved commercially-available drug to fall within the scope of traditional pharmacy practice. One factor that the agency considers in determining whether a drug may be compounded is whether the prescribing practitioner has determined that a compounded product is necessary for the particular patient and would provide a significant difference for the patient as compared to the FDA-approved commercially available drug product.
The FDA may take enforcement action against pharmacies that compound large volumes of drugs that are essentially copies of commercially available products and for which there does not appear to be a medical need for individual patients to whom the drug is dispensed.

The FDA stated it is using a risk-based approach to enforcement action against compounding pharmacies. The FDA also stated that its investigation did not identify a major safety issue, so does that mean that the FDA does not intend to take enforcement action against the compounders of hydroxyprogesterone caproate?

No. A risk-based approach to enforcement relates to how the FDA generally prioritizes its enforcement efforts. The FDA’s June 15, 2012 statement should not be interpreted to mean that the FDA will take enforcement action only if the agency identifies a particular safety problem. We reiterate that the compounding of any drug, including hydroxyprogesterone caproate, should not exceed the scope of traditional pharmacy compounding.

Links on this page:

1. /NewsEvents/Newsroom/PressAnnouncements/ucm308546.htm

Page Last Updated: 06/29/2012 

Warning Letters Matter

Warning Letters Matter

Posted by Kim Egan  on June 27, 2012

Attached is our monthly summary of selected FDA Warning Letters recently made public by FDA. Of particular note:

FDA cited one manufacturer of drug components and its immediate shipper for violation of Import for Export provisions because of failure to provide IFE records and a report, despite multiple requests by FDA.

FDA issued a warning letter to one company for promoting unapproved new drugs that made unsubstantiated claims about treatment of a wide variety of conditions, including cancer, autism, schizophrenia, multiple sclerosis, hepatitis C, and HIV infection.

FDA cited another company for making unsubstantiated therapeutic claims, including treatment of cancer and Alzheimer’s disease, about its mushroom supplements that FDA considered unapproved new drugs. In addition to inclusion of these claims on the company’s website, they were also supplemented by metatags used to bring consumers to the site.

FDA issued a warning letter to the manufacturer of a laser system for the unapproved new use of a device, as well as violation of Electronic Product Radiation Control requirements because of failure to submit product reports and file its annual report.

FDA also cited a tobacco company for violating the agency’s regulations restricting the sale and distribution of tobacco products to minors by promoting its “No Nonsense Rewards” program, wherein customers were offered a check in exchange for providing proof of purchase of specially marked packages of the company’s moist snuff product.

FDA continues to focus on Good Manufacturing Practices and posted warning letters for the following devices: steam sterilizers, an anti-embolism wrap system, lower limb prosthetics, bone densitometers, anesthetic delivery systems and respiratory therapy equipment, contact lenses, external penile rigidity devices, infusion pumps and urological catheters, neurosurgery and hemostatic devices, wound and burn dressings, temperature indicators, dental prosthetics, plasma coagulation control devices, an enteral infusion pumps, sterile syringes, an orthogonal percussion adjusting instrument, a turning medical bed, a pharmaceutical compounding device, telemetry devices, electrocardiogram monitoring equipment and software devices, a non-sterile blood pressure monitor, a total knee replacement system, a ventricular assist system, and a powered muscle stimulator device. In addition to the cGMP violations, FDA cited twelve companies for MDR violations, two for unapproved devices, two for unapproved new uses of a device, one for Report of Corrections and Removal violations, and two for Registration and Listing violations.

FDA also posted seven warning letter for cGMP violations regarding finished pharmaceuticals and dietary supplements. In addition to the cGMP violations, FDA cited one company for labeling violations, and one company for unapproved new drugs and field alert report violations.

The statistics are:

- 24 letters re cGMP device violations;

- 9 letters re medical device reporting (Animas Corporation (including cGMP violations), Health Science Products, Incorporated (including cGMP violations), APC Medical Limited (including cGMP and registration and listing violations), Teh Lin Prosthetic & Orthopedic, Inc. (including cGMP violations), Sorin Group Deutschland GmbH (including cGMP violations), The Lasik Vision Institute, Newman Lasik Centers LLC, Soring Medical Technology (including cGMP violations) and Okamoto Industries Inc. (including cGMP violations));

- 7 letters re cGMP pharma violations;

- 6 letters re unapproved new drugs (Herbal Extracts Plus, LLC, Agora Publishing Inc., Natural Health Team, The hCG Drops LLC, Mushroom Wisdom, Inc., and BioAnue Laboratories, Inc.);

- 3 letters re unapproved new use of devices (Medical Quant USA (including cGMP violations), Merit Medical Ireland Ltd. and BioElectronics Corporation);

- 2 letters re unapproved new devices (Akers Biosciences, Inc., and Spencer Forrest, Inc.);

- 2 letters re tobacco product marketing and sales (The Pinkerton Tobacco Company and Tobacco Source Three LLC);

- 1 letter re an unapproved new OTC homeopathic (Schwabe North America, Inc.);

- 1 letter re an unapproved new dietary supplement (Almased USA, Inc.);

- 1 letter re unapproved new use of an OTC device (CuraeLase, Inc. (including cGMP and MDR violations));

- 1 letter re drug study violations (Betty Tuller, Ph.D.); and

- 1 letter re import for export (MedPharm, LLC).

Here is our monthly summary of selected FDA Warning Letters recently made public by FDA. The statistics for this report:

- 24 letters re cGMP device violations;

- 9 letters re medical device reporting (Animas Corporation (including cGMP violations), Health Science Products, Incorporated (including cGMP violations), APC Medical Limited (including cGMP and registration and listing violations), Teh Lin Prosthetic & Orthopedic, Inc. (including cGMP violations), Sorin Group Deutschland GmbH (including cGMP violations), The Lasik Vision Institute, Newman Lasik Centers LLC, Soring Medical Technology (including cGMP violations) and Okamoto Industries Inc. (including cGMP violations));

- 7 letters re cGMP pharma violations;

- 6 letters re unapproved new drugs (Herbal Extracts Plus, LLC, Agora Publishing Inc., Natural Health Team, The hCG Drops LLC, Mushroom Wisdom, Inc., and BioAnue Laboratories, Inc.);

- 3 letters re unapproved new use of devices (Medical Quant USA (including cGMP violations), Merit Medical Ireland Ltd. and BioElectronics Corporation);

- 2 letters re unapproved new devices (Akers Biosciences, Inc., and Spencer Forrest, Inc.);

- 2 letters re tobacco product marketing and sales (The Pinkerton Tobacco Company and Tobacco Source Three LLC);

- 1 letter re an unapproved new OTC homeopathic (Schwabe North America, Inc.);

- 1 letter re an unapproved new dietary supplement (Almased USA, Inc.);

- 1 letter re unapproved new use of an OTC device (CuraeLase, Inc. (including cGMP and MDR violations));

- 1 letter re drug study violations (Betty Tuller, Ph.D.); and

- 1 letter re import for export (MedPharm, LLC).

And of particular note:

• FDA cited one manufacturer of drug components and its immediate shipper for violation of Import for Export provisions because of failure to provide IFE records and a report, despite multiple requests by FDA.
• FDA issued a warning letter to one company for promoting unapproved new drugs that made unsubstantiated claims about treatment of a wide variety of conditions, including cancer, autism, schizophrenia, multiple sclerosis, hepatitis C, and HIV infection.
• FDA cited another company for making unsubstantiated therapeutic claims, including treatment of cancer and Alzheimer’s disease, about its mushroom supplements that FDA considered unapproved new drugs. In addition to inclusion of these claims on the company’s website, they were also supplemented by metatags used to bring consumers to the site.
• FDA issued a warning letter to the manufacturer of a laser system for the unapproved new use of a device, as well as violation of Electronic Product Radiation Control requirements because of failure to submit product reports and file its annual report.
• FDA also cited a tobacco company for violating the agency’s regulations restricting the sale and distribution of tobacco products to minors by promoting its “No Nonsense Rewards” program, wherein customers were offered a check in exchange for providing proof of purchase of specially marked packages of the company’s moist snuff product.
• FDA continues to focus on Good Manufacturing Practices and posted warning letters for the following devices: steam sterilizers, an anti-embolism wrap system, lower limb prosthetics, bone densitometers, anesthetic delivery systems and respiratory therapy equipment, contact lenses, external penile rigidity devices, infusion pumps and urological catheters, neurosurgery and hemostatic devices, wound and burn dressings, temperature indicators, dental prosthetics, plasma coagulation control devices, an enteral infusion pumps, sterile syringes, an orthogonal percussion adjusting instrument, a turning medical bed, a pharmaceutical compounding device, telemetry devices, electrocardiogram monitoring equipment and software devices, a non-sterile blood pressure monitor, a total knee replacement system, a ventricular assist system, and a powered muscle stimulator device. In addition to the cGMP violations, FDA cited twelve companies for MDR violations, two for unapproved devices, two for unapproved new uses of a device, one for Report of Corrections and Removal violations, and two for Registration and Listing violations.
• FDA also posted seven warning letter for cGMP violations regarding finished pharmaceuticals and dietary supplements. In addition to the cGMP violations, FDA cited one company for labeling violations, and one company for unapproved new drugs and field alert report violations

FTC Workshop To Look at Pet Med Pricing

FTC Workshop To Look at Pet Med Pricing

Import Alert 66-66

Import Alert 66-66

(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).

Import Alert # 66-66

Published Date: 04/26/2012

Type: DWPE

Import Alert Name:

"APIs That Appear To Be Misbranded Under 502(f)(1) Because They Do Not Meet The Requirements For The Labeling Exemptions In 21 CFR 201.122"

Reason for Alert:

OASIS records indicate that a large volume of bulk chemicals which can be used as APIs in human medicines that require NDAs, ANDAs, or INDs are being offered for entry into the U.S.


NDA Imported APIs labeled for further manufacturing and processing or labeled as chemical substances are frequently destined for pharmaceutical processors that formulate finished drug products. These drug substances, consigned to individuals or processors who formulate and distribute human drugs, may be misbranded under Section 502(f)(1).

FY 2013 Food and Drug Administration Congressional Justification

The Food and Drug Administration conducts annual and multi-year budgeting in support of the nationwide public health protection programs administered by FDA.

The FDA produces three major budget submissions a year (HHS in June, OMB in September, and Congress in February). The budget documentation for Fiscal Year 2013, can be found here.

Jeffrey N. Gibbs Statement on Behalf of Dr. Gooberman's before NJ Board of Pharmacy Regarding Compounding Naltrexone Pellets

Statement
Of
Jeffrey N. Gibbs, Esq.
Hyman, Phelps & McNamara, P.C.
Washington, D.C.
Regulatory Counsel to Lance Gooberman, M.D.
Before The
New Jersey State Board of Medical Examiners
Special Committee Investigatory Hearing

January 17, 2000
This statement is provided on behalf of Dr. Lance Gooberman, M.D. It describes the legal and regulatory status of the practice of pharmacy compounding. It is offered to demonstrate that the practice of pharmacy compounding is legal under both federal law and New Jersey state law, that the regulatory requirements for ensuring the safety and effectiveness of compounded drugs differ significantly from the requirements for manufactured drug products, and that Dr. Gooberman's practice of compounding naltrexone pellets for subcutaneous implantation in patients undergoing opiate detoxification is consistent with those requirements.
Introduction
Compounding is an integral part of the practice of pharmacy. It is legal in all fifty states. Tens of thousands of compounded dosage forms are dispensed each day in the United States.¹
In New Jersey, compounding is defined as "the act of preparing pharmaceutical components into medications, pursuant to an authorized prescriber's medication order, including, but not limited to prescription compounding, and intravenous admixture preparation."² Like other states, New Jersey state law imposes specific requirements on the practice of compounding. For example, specific New Jersey Statutes require compounded prescriptions to be filled in the amount and with the drugs as prescribed by the practitioners.³ limit who may compound drugs and under what conditions,⁴ and establish training,⁵ documentation,⁶ and handling and delivery requirements for compounded prescriptions.⁷
However, nothing in New Jersey law says that a pharmacist must have a specified amount of data before compounding a drug, or that a physician must have a specified amount of data before prescribing a Compound drug. And, in fact, requiring a specified amount of data in advance is entirely incompatible with compounding. Physicians often prescribe a compounded drug to meet the unique needs of a single patient. Obviously, there can be no prior clinical experience in that situation.
The practice of pharmacy compounding is distinctly different from the process of drug manufacturing. The U.S. Pharmacopoeia (USP), an authoritative reference for establishing drug standards, describes the characteristics that differentiate compounding from manufacturing. They include: "the existence of specific practitioner-pharmacist-patient relationships; the quantity of medication prepared in anticipation of receiving a prescription or a prescription order; and the conditions of sale, which are limited to specific prescription orders."⁸
The USP has established a monograph that describes the standards for pharmacy compounding. USP took this action in express recognition of the importance of compounding. Significantly, although USP sets our detailed standards for compounding, it does not require that there be test done before a drug is compounded.
Similarly; the National Association of Boards of Pharmacy (NABP), to which most state boards of pharmacies belong, has created detailed standards for drug compounding, NABP's standards have been widely adopted by the states. However, the NABP's standards do not require that a pharmacist or physician possess any clinical data before compounding.
Compounding is most frequently necessary when the patient requires a drug that is not available commercially. Because approval of a new drug application is a time consuming and expensive process, manufacturers generally only develop drugs in the strengths and dosage forms that are most likely to ensure a return on their investment. If a particular patient needs a drug in a different strength or dosage form, compounding is the means by which the physician can provide the drug to that patient. Compounding is also useful for medications that are not stable and which must be prepared in small quantities, or when the patient is allergic to something (e.g. a dye) in the commercially available form of the drug.
In 1938, Congress passed the first statute regulating the distribution of drugs. As subsequently amended, federal law requires that before the drug may be marketed, the drug company must demonstrate that he drug is safe and effective for its intended use. As a result, drug companies must undertake one or more clinical studies of sufficient size to demonstrate the safety and effectiveness of the product.⁹ By contrast, a compounded drug is not intended for general use. Thus, the regulatory scheme for ensuring the safety and effectiveness of compounded drugs is necessarily different than that for manufactured drug products.
In 1997, Congress established the regulatory scheme that now governs the practice of pharmacy compounding. The strategies selected by Congress to ensure the safety and effectiveness of compounded drugs clearly reflect the characteristic differences between compounded and manufactured drug products. The federal regulatory scheme focuses on controlling the process of compounding. It does not require a statistically significant assessment of the safety and effectiveness of the final drug product, as that assessment would be irrelevant to the needs of the patient for whom the compounded prescription was prescribed.
Pharmacy Compounding: The Federal Regulatory Requirements
Prior to 1997, the Food and Drug Administration (FDA) had taken the position that pharmacies that compounded were subject to the new drug approval (NDA) and good manufacturing practice (GMP) requirements of the Federal Food, Drug, and Cosmetic Act (FDC Act). According to the FDA, every time a pharmacy compounded a drug, it needed to comply with the GMP and NDA provisions of the FDC Act. While FDA said that in the exercise of its enforcement discretion, it would normally not require pharmacies to comply with the GMP and NDA requirements, the agency also said that it had the power to compel compliance. Under those standards, compounded drugs were - n theory - subject to the same standards for safety and efficacy as drugs manufactured for use in the general population. Congress disagreed with that approach.
In 1997, Congress amended the FDC Act by adding Section 503A which governs the practice of pharmacy compounding. Section 503A which governs the practice of pharmacy compounding. Section 503A exempts compounded drugs from the new drug approval and good manufacturing practice requirements of the FDC Act, provided that the drugs are compounded in accordance with specified criteria.
These criteria include limiting compounding to licensed pharmacists and physicians, and restricting the type and quality of the materials that may be used. It is through adherence to these criteria that the safety and efficacy of compounded drug products is achieved. Therefore, a pharmacist who compounds a drug in accordance with these criteria is exempt from the NDA, GMP and labeling provisions that govern the development of drug products manufactured for use in a broader population of patients.¹⁰ Thus, there are no requirements for evaluating the safety or efficacy of the final compounded drug in animal or human trials. The statute does not require test data even if a compounded drug is widely prescribed and dispensed to thousands of patients.
In enacting the pharmacy legislation, Congress was well aware of the fact that new drugs generally require controlled clinical trials. Nevertheless, Congress exempted compounded drugs from the need to meet this standard. Congress recognized that compounding, by its very nature, should not have to meet the safety and efficacy standards that apply to manufactured drugs.
Compounding of Depo-Naltrexone Pellets
Dr. Gooberman's practice of compounding depo-naltrexone in pellet form for subcutaneous implantation in patients undergoing opiate detoxification is consistent with the criteria established by Congress for pharmacy compounding in Section 503A. Section 503A provides that compounding may only be performed by a licensed pharmacist or licensed physician subject to receipt of a valid prescription for an identified Patient. Dr. Gooberman complies with this requirement because he, as a licensed physician, prescribes compounded depo-naltrexone in pellet form form for subcutaneous implantation in individually identified patients.
Section 503A also places limits on the type of drugs that may be used in compounding. According to Section 503A(b), a licensed pharmacist may compound a drug product using bulk drug substances that comply with the applicable USP or National Formulary (NF) monograph, when a monograph exists, as well as the USP chapter on pharmacy compounding. Naltrexone is covered by a USP monograph.
Any drug withdrawn from the market because it was found to be unsafe or not effective, or any drug which presents "demonstrable difficulties" for compounding that reasonably demonstrate an adverse effect on the safety or effectiveness of that drug product, may not be used in compounding.¹¹ Naltrexone is an FDA approved drug that has not been withdrawn from the market for reasons concerning its safety or effectiveness, nor has it been identified by FDA as a drug which presents "demonstrable difficulties" for compounding. Therefore, it meets these criteria.
Section 503A also places limits on the quantity of drug that may be compounded. This includes a prohibition on "regular" compounding, or compounding in "inordinate" amounts, of drug products which are essentially copies of commercially available drugs.¹²
Naltrexone is not commercially available in the pellet form prescribed by Dr. Gooberman. Orally administered forms of the drug are commercially available and are currently used as adjunctive therapy during the detoxification process for the purpose of blocking the pharmacological effects of exogenously administered opioids. The utility of orally administered naltrexone is limited, however, as dosing is dependent upon patient compliance. Because the drug is prescribed for patients whose lifestyles may make compliance extraordinarily difficult, the rate of relapse is high. Depo-naltrexone in the pellet form is considered significantly different from oral naltrexone. Thus, compounding of the drug in this form is not considered compounding of a drug that is otherwise commercially available, and this limitation therefore does not apply to the pellets compounded by Dr. Gooberman.
While compounding may be limited to a single formulation for a single patient, that is not necessarily the case. Under Section 503A, a pharmacist can compound larger quantities of a drug, such as depo-naltrexone, for multiple patients and still not need FDA approval. Accordingly, Dr. Gooberman's prescription of depo-naltrexone for multiple patients is not inconsistent with Section 503A.
The law also intends there to be limits on the quantity of compounded drugs that may be shipped across state lines by individual pharmacists or pharmacies. Specifically, Section 503A seeks to limit the interstate distribution of "inordinate amount" in this context is to be established by FDA with each state through a Memorandum of Understanding (MOU). FDA has said that it will not enforce this provision until an MOU is adopted. FDA has not yet adopted an MOU.
Thus, Dr. Gooberman's prescriptions for compounded depo-naltrexone comply with FDA's requirements. He therefore does not need to have clinical data to prescribe this compounded medication.
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1. International Academy of Compounding Pharmacists, The Art and Skill of Compounding,http://iacprx.org/about_compounding.htm.
2. N.J.A.C. § 13:39-1.2(1999).
3. N.J.A.C. § 45:14-16(1999).
4. N.J.A.C. § 13:39-9.8(1999).
5. N.J.A.C. § 13:39-11.7(1999).
6. N.J.A.C. § 13:39-11.10(1999).
7. N.J.A.C. § 13:39-11.13(1999).
8. United States Pharmacopeia, Pharmacy Compounding Practices, USP 24-NF 19,2118.
9. 21 U.S.C. § 355(d)
10. 21 U.S.C. § 353a.
11. 21 U.S.C. § 503A(b)(1)(D).
12. 21 U.S.C.§ 503A(b)(1)(D)