Saturday, October 6, 2012

Article from Boston Globe Notes That New England Compounding Center is under Investigation by State and Federal Authorities After Meningitis Outbreak


Compounding pharmacy oversight is questioned after meningitis outbreak

By Liz Kowalczyk and Kay Lazar

| Globe Staff October 06, 2012

Compounding pharmacies started as small mom-and-pop stores that mixed hard-to-find medications for local doctors and their patients who had allergies, difficulty swallowing, or otherwise could not take mass-produced drugs.
But amid growing drug shortages in the pharmaceutical industry, some large compounders such as the New England Compounding Center stepped in and ­expanded their business far beyond the industry’s homespun roots.
The Framingham company, whose products are implicated in a nationwide outbreak of fungal meningitis that sickened more people Friday, listed dozens of products online and apparently took thousands of orders from doctors, clinics, and hospitals in at least 23 states, a transformation that regulators have not kept pace with, critics and even some industry executives said.
To read the rest of the article click here.

Friday, October 5, 2012

Steroid firm was investigated by Mass. in 2006

Steroid firm was investigated by Mass. in 2006

Statement Suggests Pharmacy May Have Violated Law - NewsChannel5.com | Nashville News, Weather & Sports

Statement Suggests Pharmacy May Have Violated Law - NewsChannel5.com | Nashville News, Weather & Sports

Drug Safety and Availability Questions and Answers on Fungal Meningitis Outbreak

Drug Safety and Availability Questions and Answers on Fungal Meningitis Outbreak

FDA expands recall list of tainted drugs as meningitis outbreak grows to 47 cases

Federal health officials have expanded the recall list of potentially contaminated injectable medications suspected in a multi-state meningitis outbreak and the death of five peopleMore and more cases are being reported, with 47 people having contracted meningitis in seven states. 

The Food and Drug Administration released a list of 34 different drugs this morning that included steroids, epidural anesthetics used to block pain during childbirth, and surgery and saline solutions that are compounded to make different medications. All of the products on the recall list were made by the New England Compound Center (NECC) in Framingham, Mass., and are administered by injection into the spine. ..

..The Centers for Disease Control and FDA have asked the clinics, doctors offices and hospitals in 23 states that have received shipments of medications from NECC to stop using them immediately. Anyone who has received epidural injections since July 1 should watch for symptoms of meningitis. Health officials say the most common symptoms are worsening headache, fever, stiff neck, trouble walking or falling and progressing back pain. Many of these patients have suffered strokes.
Click for a full list of recalled drugs from the FDA...


Read more: http://www.foxnews.com/health/2012/1...#ixzz28TEFI9Uk

Why the New England Compounding Center Meningitis Outbreak, As Tradgic As It Is, Should Not Mean No More Compounded Drugs or Medications and No More Compounding Pharmacies


This is a previous post that has been updated.  It is now more important than ever not to lose sight of the fact that compounded medications are essential to both pets and humans.  Do changes in regulations, laws,and enforcement need to be made.  Yes, that is clear.  However, do compounded drugs need to be a thing of the past. No, absolutely not. This post  will hopefully help to explain some of the reasons: Why We Need and Must Have Compounded Medications.

In the wake of the tragic deaths in the New England Compounding Center case, Franck's (Florida), Apothecure (Texas) and Meds IV (Alabama), it is important to not lose sight of the fact that we need and must have compounded medications.    If these medications were not available, some patients  (both humans and animals) would suffer and some could die. This was explained by Loyd V. Allen, Jr., Ph.D., R.Ph., Editor-in-Chief, International Journal of Pharmaceutical Compounding, when he testified on April 19, 2007, before the U.S. Senate Special Committee on Aging in Washington, DC.  During his testimony he explained:

Millions of Americans have unique health needs that off-the-shelf prescription medicines cannot meet. For many of them a customized, compounded medication prescribed by licensed physicians or veterinarians and mixed by trained, licensed compounding pharmacists are the only way to better health. If customized medicines were not available, some of our most at-risk patients would needlessly suffer and some would die.

Allen also gave excellent examples of those who rely on compounded medications:

• Infants and children: Compounding pharmacists can transform medicines from
hard-to-swallow pills intended for adults into syrups, elixirs, suspensions, and
emulsions for children, at the request of physicians. Flavors offered by
compounding pharmacists can make drugs more palatable to children. In
addition, premature infants often rely on lifesaving and life-sustaining drugs made
only in compounding pharmacies.
• Hospital patients: Many, if not most, of the lifesaving intravenous drugs given in
hospitals and clinics are compounded. Because hospital patients are often on
multiple medications, compounding them into one treatment saves the hospital
personnel time and the patient multiple injections or administrations.
• Cancer patients: Cancer treatment often involves special mixtures of cancer drugs
that are compounded pursuant to a doctor’s prescription. Pharmacists can
combine multiple drugs into one treatment, leading to shorter administration times
for cancer patients.
• Senior citizens: Elderly patients often have difficulty with traditional dosage
forms, such as pills taken orally. Compounding pharmacists create alternate
methods of delivery, like transdermal gels, to make it easier for the elderly to take
their medicine.
• Pets: Animals come in all shapes and sizes, so one-size-fits-all pharmaceuticals do
not always meet their needs. In many cases, a compounded medication may be
necessary for a non-food animal to be satisfactorily treated.
• Patients with allergies: Patients who are allergic to a preservative, dye, flavor or
other ingredient in commercial products can have their doctor write a prescription
for a compounding pharmacist to customize the same medication without the
offending ingredient.
• Menopausal women: Many women experience significant pain and discomfort as
their bodies’ progress through menopause. Doctors prescribe bioidentical
hormones for patients for whom synthetic hormone treatments may be ineffective
or produce undesired side effects. Several bioidentical hormone products are
available in FDA-approved, one-size-fits-all formulations from pharmaceutical
companies. However, physicians may determine that their patients have unique
needs that warrant prescribing a different compounded hormone treatment. This
often allows patients to take the smallest amount of a given hormone preparation
to treat their symptoms, in conjunction with the recommendation provided by the
Women’s Health Initiative study.
• Patients who require non-traditional dosage forms: Many patients are unable to
take medications orally or as injections – the traditional dosage forms for
manufactured drugs. Compounding pharmacists can create alternate methods of
delivery, like ointments, solutions or suppositories, to fit these patients’ unique
health needs. The pharmaceutical industry supplies only limited strengths of
drugs, which some patients cannot tolerate. It is often necessary for a doctor to
request a different strength of a drug for a patient through compounding.
• Patients who rely on discontinued drugs: Pharmaceutical manufacturers have
discontinued thousands of drug products over the years, due to low profitability.
For certain groups of patients, these were very effective, important, and
sometimes life-saving medications. Such medications are now only available if a
doctor prescribes them to be compounded.
• Hospice patients: End-of-life therapy involves the compounding of many different
and unique dosage forms to allow patients to live out their lives free of pain and
discomfort. Many combinations of drugs are prescribed by doctors and used for
these patients who cannot swallow medications and who don’t have the muscle
mass that is required to receive multiple injections each day. Compounding
pharmacists can provide alternate delivery methods such as oral inhalation, nasal
administration, topical, transdermal or rectal use.
These are important examples of why we need and must have compounded medications in the United States.  The problems in the tragic cases do not suggested that the practice of compounded medications must be stopped; instead, the tragedies shows that the rules and regulations relating to compounding need to be complied with by pharmacies, doctors, veterinarians and enforced by state boards of pharmacy, state boards of medicine, state veterinary boards and the United States Food and Drug Administration.   To read the entire transcript of Dr. Allen's testimony, click here.

Hundreds may be at risk in meningitis outbreak

Hundreds may be at risk in meningitis outbreak

Clinics Scramble to Notify Patients at Risk of Meningitis


The number of people who contracteda rare and deadly fungal meningitis linked to steroid injections expanded to 47 cases in seven states, federal officials said Friday, as health providers rushed to notify thousands who may have been exposed.
Health officials in 23 states from New Jersey to Nevada said they were recovering potentially tainted vials and notifying patients who may have received the steroid injections for back pain between July and late September. The death toll remained at five as of Friday evening.
To read the rest of the article click here.

Close to 18,000 doses of the drug, methylprednisolone acetate, have been recalled by the Massachusetts pharmacy that made it.

To read the NPR report click here

Map of Healthcare Facilities which Received Lots of Methylprednisolone Acetate (PF) Recalled from New England Compounding Center on September 26, 2012

Click here to view map.

47 people: 7 states now linked to infection

To read report and see news report click here.

Our Mixed Up Views On The Mixed Up Medicines Responsible For Deadly Meningitis

To read the Forbes article click here.

Meningitis Outbreak Places Spotlight on FDA's Regulation of Compounding Pharmacies RAPS News - Article View

Meningitis Outbreak Places Spotlight on FDA's Regulation of Compounding Pharmacies RAPS News - Article View

Joint Telebriefing of CDC and FDA

To view transcript, click here.

NORTH CAROLINA BOARD OF PHARMACY SUMMARILY SUSPENDS NEW ENGLAND COMPOUNDING CENTER’S PHARMACY PERMIT


WEDNESDAY, OCTOBER 3, 2012
NORTH CAROLINA BOARD OF PHARMACY SUMMARILY SUSPENDS NEW ENGLAND COMPOUNDING CENTER’S PHARMACY PERMIT NUMBER 08439.  The Board of Pharmacy today summarily suspended out-of-state pharmacy permit number 08439 held by the New England Compounding Center, 697 Waverly Street, Framingham, Massachusetts 07102.  Board staff strongly advises any pharmacy or other health care facility in North Carolina that has any sterile product compounded by New England Compounding Center to take immediate, appropriate action.  The Board’s summary suspension order may be found here (click here).
North Carolina clinicians are advised to be alert for communications from North Carolina Public Health concerning this matter.
More information concerning the circumstances leading to the Board’s action may be found here: 

Thursday, October 4, 2012

Meningitis outbreak: Oklahoma hasn’t seen any cases of fungal meningitis

Meningitis outbreak: Oklahoma hasn’t seen any cases of fungal meningitis

Illnesses Fuel Scrutiny of Pharmacies


A meningitis outbreak that has now killed five patients and sickened 35 is focusing renewed attention on the little-regulated world of drug-mixing pharmacies, after injections made by a Massachusetts facility were tied to the illnesses.
The New England Compounding Center surrendered its state license to operate on Wednesday, the state health department said. Officials urged doctors and hospitals to avoid the pharmacy, which prepared steroid injections for lower back pain that are being investigated for possible contamination.
Officials at the pharmacy couldn't be reached for comment.
To read the rest of the Wall Street Journal Article click here


Board probed pharmacy tied to meningitis

Board probed pharmacy tied to meningitis

Is it a Question of Oversight?


In a Drug Linked to a Deadly Meningitis Outbreak, a Question of Oversight
The growing outbreak of meningitis was a calamity waiting to happen — the result of a lightly regulated type of drug production that had a troubled past colliding with a popular treatment.http://www.nytimes.com/2012/10/05/health/news-analysis-a-question-of-oversight-on-compounding-pharmacies.html?smid=pl-share

List of 23 States that Received Compounded Injection from New England Compounding Center

Twenty-three states have received medication from NECC among the three recalled lots: California, Connecticut,  Florida, Georgia, Idaho, Illinois, Indiana, Maryland, Michigan, Minnesota, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Virginia, Texas and West Virginia.

To read more click here

The International Academy of Compounding Pharmacists Responds to Meningitis Outbreak Tied to Compounding Pharmacy

The International Academy of Compounding Pharmacists Responds to Meningitis Outbreak Tied to Compounding Pharmacy

FDA: Avoid drugs from company tied to meningitis


Updated 1:38 p.m., Thursday, October 4, 2012EW YORK (AP) — U.S. health officials ramped up warnings Thursday about a Massachusetts specialty pharmacy linked to a widening outbreak of a rare kind of meningitis, urging doctors and hospitals not to use any products from the company.
Investigators this week found contamination in a sealed vial of the steroid at the New England Compounding Center in Framingham, Mass., according to Food and Drug Administration officials.
Tests are under way to determine if it is the same fungus blamed in the outbreak that has sickened 35 people in six states. Five of them have died. All received steroid shots for back pain.
"Out of an abundance of caution, we advise all health care practitioners not to use any product" from the company, said Ilisa Bernstein, director of compliance for the FDA's Center for Drug Evaluation and Research.
The company recalled the steroid medication last week and has shut down operations. The recalled steroid had been shipped to facilities in 23 states since July.
The type of fungal meningitis involved is not contagious like the more common forms. 

Read more: http://www.sfgate.com/news/article/FDA-Avoid-drugs-from-company-tied-to-meningitis-3916606.php#ixzz28Mt2uvJ6




Regulators scrutinize arcane realm of pet drug sales

October 3, 2012
By: Jennifer Fiala
For The VIN News Service 

The markup on pet medications sold in Dr. Link Welborn’s Tampa-area veterinary practices is half of what it was three years ago due to price cuts compelled by competition for drug sales.

Still, Welborn writes prescriptions daily in hopes that owners who save money on medications might spend more on needed medical care. He’d rather run blood work to help identify the cause of a patient’s illness than merely sell an antibiotic to treat some mystery infection.

“Virtually every veterinary visit includes two conversations: one about care and one about costs,” Welborn said Tuesday at Federal Trade Commission (FTC) offices in Washington, D.C. “Veterinarians help pet-owning consumers spend their money wisely every day.”

Welborn’s insight culminated eight hours of panel talks to explore whether government action is needed to ensure that consumers can price shop for pet medications. Traditionally, veterinarians both prescribe and sell drugs — a system that some consider a conflict of interest. With online pharmacies and retailers seeking a slice of the pet medications market, competitors want to require veterinarians to provide prescriptions automatically to pet owners, whether requested or not. 
In response, FTC officials are eyeing the pet product distribution landscape, anticipating that the passage of a bill in Congress will require the agency to promulgate rules related to veterinary prescriptions.

The Fairness to Pet Owners Act of 2011, or HR 1406, is buried in a House subcommittee where it’s unlikely to emerge for a vote this year. Nevertheless, the FTC is paying attention. Charged with protecting consumers, agency officials called for Tuesday’s workshop to determine how pet owners are impacted by a convoluted distribution system characterized by exclusionary sales policies and clandestine transactions. 
Drug company officials, antitrust lawyers, online pharmacy representatives, leaders with the American Veterinary Medical Association (AVMA) and a former Wal-Mart insider are among those who gathered to debate the issues. While some accused veterinarians of engaging in anticompetitive behavior by discouraging clients from shopping outside their practices, many pointed the finger at manufacturers that have policies to limit product sales to practicing veterinarians. 

To read rest of article click here

Press Announcements FDA takes action against thousands of illegal Internet pharmacies

Press Announcements FDA takes action against thousands of illegal Internet pharmacies

Outbreak spotlights risks from custom-mixed drugs

Outbreak spotlights risks from custom-mixed drugs

FDA cracks down on thousands of websites for selling bad drugs


(Reuters) - The U.S. Food and Drug Administration on Thursday said it has cracked down on thousands of online pharmacies for selling potentially unsafe, unapproved or fake pharmaceuticals, including the erectile dysfunction drug Viagra and antiviral Tamiflu.
The FDA, working with international regulatory and law enforcement agencies from about 100 countries, said it took action against more than 4,100 Internet pharmacies, bring civil and criminal charges, removing offending websites and seizing drugs worldwide.
The move was part of the fifth annual International Internet Week of Action, a global effort to fight the online sale and distribution of potentially counterfeit and illegal medicine.
To read the rest of the article click here

W.Va. official: 1 clinic got recalled medication


Published 10:44 a.m., Thursday, October 4, 2012



CHARLESTON, W.Va. (AP) — A West Virginia clinic received a steroid medication suspected in an outbreak of a rare form of meningitis, the head of the state Bureau for Public Health said Thursday.
Dr. Marian Swinker didn't immediately identify the clinic and said her office's epidemiology staff is closely monitoring the situation with the federal Centers for Disease Control and Prevention. The steroid injections are mostly used for back pain.
"We understand that CDC has contacted that clinic and that patients who may have received the medication in question will be contacted for follow-up," Swinker said.


Read more: http://www.sfgate.com/news/article/W-Va-official-1-clinic-got-recalled-medication-3919296.php#ixzz28MDcORCM

5 people now dead; In all, 35 people in six states have been sickened from a steroid compounded by the New England Compounding Center that was distributed to 23 states, the Centers for Disease Control and Prevention said.

For more details, click here

Hundreds at risk in meningitis outbreak Health officials are now trying to track down people in 23 states who got epidural steroid injections. NBC’s Robert Bazell reports.

To view this video, click here.

Meningitis Outbreak Is Growing As More Are Being Reported Sick


Rare US meningitis outbreak grows; 4 dead, 22 sick

Updated 5:18 a.m., Thursday, October 4, 2012
Read more: http://www.sfgate.com/news/article/Rare-US-meningitis-outbreak-grows-4-dead-22-sick-3916606.php#ixzz28KotOAqR

Vandy doctor alerted health officials about meningitis problem - WAFF-TV: News, Weather and Sports for Huntsville, AL

Vandy doctor alerted health officials about meningitis problem - WAFF-TV: News, Weather and Sports for Huntsville, AL

Some say FDA oversight needed State boards lack staff to fully monitor


The fungal meningitis outbreak centered on Nashville has renewed debate over who should regulate specialty pharmacies that compound medicines.
While they fall under the purview of state pharmacy boards, critics contend those state agencies are often too understaffed and underfunded to adequately monitor such facilities. They want the U.S. Food and Drug Administration to take a greater regulatory role.
But the FDA has said it will do that only on a case-by-case basis — such as the meningitis outbreak that surfaced in Nashville and has since spread to four other states.

To read the rest of the article click here.

Wednesday, October 3, 2012

In Outbreak, Meningitis Is Reported in 5 States



The outbreak of a type of meningitis linked to back pain injections has spread, with over 30 cases, four of them fatal, in Tennessee, North Carolina, Florida, Virginia and Maryland.http://www.nytimes.com/2012/10/04/health/meningitis-outbreak-grows-with-cases-in-5-states.html?smid=pl-share

Report Urges FDA to Approve More Drugs


By David Pittman, Washington Correspondent, MedPage Today

WASHINGTON -- The FDA should set a goal of doubling the number of new drug approvals over the next 10 to 15 years and can approve products for smaller populations to do so, White House advisers said.
The agency can approve drugs with a narrower indication for which a drug is safe and effective, and protect a broader population from unknown or unfavorable risks, the President's Council of Advisors on Science and Technology (PCAST) said in a 110-page report.
"It would require a special designation that would strongly discourage prescribers from using these drugs off-label and discourage payors from reimbursing off-label use," stated the report, Propelling Innovation in Drug Discovery, Development, and Evaluation, released last week.
Off-label use "has contributed to discoveries of useful applications of drugs to non-approved uses, but it can also pose serious risks to patients," PCAST said.
The report follows President Obama's request to examine ways to improve the drug development and review process. Many advancements in biomedical research haven't translated to new medicines for the betterment of public health, the council said.
To read the rest of the article click here.

Pharmacy suspends operations after meningitis outbreak

Pharmacy suspends operations after meningitis outbreak

Rare meningitis cases at 26 in 5 states, 4 deaths

To read this article click here

To read another related article click here

More on the New England Compounding Center


The Wall Street Journal has an article regarding the New England Compounding Center entitled, Meningitis Tied to Pharmacy: Authorities Investigate Maker of Steroid Injections Linked to Deadly Outbreak.  To read the article click here.

Pharmacy suspends operations after meningitis outbreak - WSMV Channel 4

Pharmacy suspends operations after meningitis outbreak - WSMV Channel 4

Tennessee Board of Pharmacy Board Meeting involved a complaint about a compounding pharmacy

The July 26-27, 2012 Tennessee Board of Pharmacy Board Meeting involved a complaint about a compounding pharmacy that was making commercially available products.  The complaint was dismissed.  Here is the entry from the meeting minutes:

Anonymous complaint alleged that compounding pharmacy compounded commercially available products (Untraflex and/or Neuro-Gel Plus) and shipped them to physicians’ offices in a contiguous state.
Investigation revealed that pharmacy is not compounding commercially available products and that the products are being billed as prescribed.
Prior discipline:   none
Recommendation:   Dismiss

Apothecure, Inc. and Gary Osborn Get No Jail Time: $100,000 Fine Imposed

The judge has sentenced Gary Osborn on Counts 1-2 to 1 year of probation and imposed a $100,000 fine.  The judge has sentenced Apothecure Inc., Counts 1-2 to 5 years of probation and imposed a $100,000 fine.


Meningitis Cases Are Linked to Steroid Injections in Spine



WZTV FOX 17 :: Newsroom - Top Stories - Steroid Injections May Have been Contaminated Out of State

WZTV FOX 17 :: Newsroom - Top Stories - Steroid Injections May Have been Contaminated Out of State

Meningitis Investigators Eye Link To Compounding Pharmacy - NewsChannel5.com | Nashville News, Weather & Sports

Meningitis Investigators Eye Link To Compounding Pharmacy - NewsChannel5.com | Nashville News, Weather & Sports

Pharmacy Automation Market to Grow at 8% CAGR to 2017: New Market Research Report at ReportsnReports.com


PRWeb – Sun, Sep 30, 2012

Dallas, Texas (PRWEB) September 30, 2012
This report says global inpatient and outpatient pharmacy automation market was valued at $2.4 billion in 2011 and should reach $2.6 billion in 2012. Total market value is expected to reach nearly $3.9 in 2017 after increasing at a five-year compound annual growth rate (CAGR) of 8%. The inpatient segment of the pharmacy automation market is expected to have a value of nearly $2 billion in 2012 and more than $2.8 billion in 2017, a CAGR of 7.3%. The outpatient segment should total $636 million in 2012 and $1 billion in 2017, a CAGR of 10.1%.
Although pharmacy automation dates back to the 1970s with the introduction of pill-counting machines, the pharmacy automation market continues to advance and deliver impressive technology and improve efficiency. The increasing demand for accuracy, safety, industry standards and competency in the pharmacy environment by regulatory authorities, manufacturers, healthcare professionals and consumers has forced the growth of this market.  To read the rest of the report, click here.

Tuesday, October 2, 2012

FDA shoots warning across bow of CanadaDrugs.com Reports tie Internet drug company to FDA's probe of counterfeit Avastin Read more: FDA shoots warning across bow of CanadaDrugs.com - FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/story/fda-shoots-warning-across-bow-canadadrugscom/2012-10-02#ixzz28CzxTTp8 Subscribe: http://www.fiercepharmamanufacturing.com/signup?sourceform=Viral-Tynt-FiercePharma Manufacturing-FiercePharma Manufacturing

October 2, 2012 | By Eric Palmer


The FDA has sent a warning letter to one of the most prolific Internet drug providers from Canada, which reports have tied to an investigation of counterfeits of the cancer drug Avastin that were sold to physician practices in the U.S. this year.
The agency this week posted a warning letter sent to a lawyer in Manitoba claiming that hundreds of websites it identified, including CanadaDrugs.com, were offering for sale drugs made at unapproved facilities. It said the sites were even offering domperidone, which it said is no longer approved for sale in the U.S. because of dangers to breastfeeding women.

A similar warning letter regarding "Arkadiy Kisin/White Forest Solutions" was also sent to a series of email addresses and lists dozens of Internet pharmacy sites offering contraceptives and "unapproved drugs" including Accutane, which it says has not been approved for sale in the U.S. since 2010.

An investigation this year by The Wall Street Journal tied the owner of CanadaDrugs.com, Kris Thorkelson, to a probe by federal authorities into companies that the FDA said supplied counterfeit Avastin to U.S. doctors. It said subpoenas sent to physicians asking for information about where they obtained the drugs named Thorkelson. The warning letter says, the "FDA is taking this action against your firm because of the inherent risk in buying unapproved and misbranded new drugs." It gives the companies 10 days to respond.
The FDA in February and April discovered the counterfeit cancer drugs. Some of the recovered boxes were labeled Altuzan, which is the brand name for Avastin in Turkey. Tests, however, determined that there was no active ingredient in the counterfeits. So far, there have been no reports of problems related to the drugs, according to the FDA and Genentech, the Roche ($RHHBY) unit that makes the cancer treatment.


Read the remainder of the article here
The warning letter to CanadaDrugs.com
The letter to Arkadiy Kisin/White Forest Solutions


Dr. Margaret Hamburg, FDA Commissioner, delivering the keynote address at the 2012 Interchange. Image courtesy of C-SPAN. Leading Health Care, Law Enforcement and Government Officials Join with Industry and Patient Advocates to Assess State of Counterfeit Medicines


.S. FDA Commissioner Hamburg Urges Physicians, Patients to Only Purchase Medicines from Reliable Sources to Better Protect Against Fake Drugs
Washington, D.C. (September 28, 2012)The Partnership for Safe Medicines (PSM) today convened leading domestic and international stakeholders in the fight against counterfeit and substandard medicines, making a renewed commitment to work together and implement new solutions to protect patients worldwide. U.S. Food and Drug Administration Commissioner Dr. Margaret Hamburg, in a keynote to the conference, highlighted new efforts her agency is undertaking to reduce the threat and pledged the FDA’s ongoing support to ensure a safe U.S. drug supply.
"The American people have every right to expect that the medicines they rely on are exactly what the package and label say they are – and that the medicines have been carefully evaluated by FDA for safety, efficacy, and quality," said FDA Commissioner Margaret A. Hamburg, M.D. "Our success in addressing this global challenge will depend on collaborating with public health and regulatory partners here in the United States and around the world."
PSM Executive Director Scott LaGanga.
Image courtesy of C-SPAN.
The event brought together more than 140 participants, representing government, health care, law enforcement and patient advocacy. This is the third year that PSM has hosted a global Interchange event in Washington, D.C.
“This year’s Interchange was our boldest, most ambitious effort to date,” said PSM President Dr. Marvin D. Shepherd. “By bringing together stakeholders from as far away as India and Great Britain to share information and ideas on how to win the war on counterfeit medicines, we are sending a message to counterfeiters worldwide: the noose is tightening, and you can’t hide forever. As regulators and law enforcement agencies in the U.S. and abroad come to grips with the great public health risk of fake drugs, our efforts and successes will only intensify in the future.”  To read more click here

Monday, October 1, 2012

New FDA hand-held scanner sheds light on counterfeits Agency might sell its patented device to other regulators September 27, 2012 | By Eric Palmer Read more: New FDA hand-held scanner sheds light on counterfeits - FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/story/new-fda-hand-held-scanner-sheds-light-counterfeits/2012-09-27?utm_source=rss&utm_medium=rss#ixzz284qKoVCa Subscribe: http://www.fiercepharmamanufacturing.com/signup?sourceform=Viral-Tynt-FiercePharma Manufacturing-FiercePharma Manufacturing


Agency might sell its patented device to other regulators


Read more: New FDA hand-held scanner sheds light on counterfeits - FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/story/new-fda-hand-held-scanner-sheds-light-counterfeits/2012-09-27?utm_source=rss&utm_medium=rss#ixzz284qSCJAx
Subscribe: http://www.fiercepharmamanufacturing.com/signup?sourceform=Viral-Tynt-FiercePharma Manufacturing-FiercePharma Manufacturing

Drug giants fined $11bn for criminal wrongdoing; Fines are not enough to reform drug industry, warn lawyers


The Independent has an article entitled Drug Giants Fined $11bn for Criminal Wrongdoing, written by Jeremy Laurance and published September 20, 2012.  To read this article click here.

Washington State Board of Pharmacy: Ther-Rx Corp Letter


The Washington State Board of Pharmacy had on its September 27, 2012 agenda to discuss:

3.10 Correspondence. The board may discuss any correspondence received or distributed. Information/Action.
a) Ther-Rx Corp. letter re: Compounding of Hydroxyprogesterone Caproate

Once the minutes to the meeting are posted, I will update you on what position the Washington State Board of Pharmacy has taken.

Another FDA lawsuit over Exclusivity


FDA Law blog is reporting  that there is another  Orphan Drug Battle in that Depomed has Sued the FDA Over GRALISE Orphan Drug Exclusivity.  The complaint and post can be read here.