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Food Safety Update: January, 2013

January 30, 2013 by

While the FDA’s proposed rules aimed at preventing foodborne illness are in their comment period, the troubling trend of food related recalls continues. Since January 1, 2013, the FDA has reported 14 food recalls for safety reasons. These recalls are based on contaminated products, undeclared ingredients and metal fragment contamination. Among the recalls:

  • Annie’s Inc., is recalling frozen pizza products that contain metal fragments. According to the company, a fine metal mesh screen failed at a third-party flour mill and fragments of the metal mesh have been found in flour and pizza dough.
  • Knott’s Fine Foods recalled chicken salad sandwiches due to their possible contamination with Listeria monocytogenes which is especially serious in the elderly, children, pregnant women and those with weakened immune systems. The sandwiches were sold in three states over 35 retail stores.
  • Belmont Confections recalled numerous lots of cookie and brownie bars that contain undeclared peanuts, after becoming aware of the problem by a distributor. The bars were distributed both in the United States and internationally from March to December of 2012.

These recalls highlight the issues the FDA is tackling with food safety in the United States. In its most recent Center for Food Safety ”Constituent Update,” the FDA reported that it had “reinstated the food facility registration of Sunland Inc., a manufacturer and distributor of peanut products linked to an outbreak of Salmonella Bredeney last fall, after a federal judge entered a consent decree of permanent injunction imposing requirements on the firm.” This reinstatement came after Sunland Inc., was found to be the source of a 2012 tainted peanut butter outbreak.

Currently the FDA has no scheduled meetings regarding food safety, but a number of dockets are currently open for public comment regarding different food safety issues and proposed regulations.

Filed Under: Food, Food & Drug Administration, Food Safety Modernization Act, Government Document, HHS

New York City Gets Inventive in Its Crackdown on Opioid Abuse

January 25, 2013 by

The growing problem of prescription drug abuse, particularly in relation to opioids, has been a hot topic for federal and local government officials over the past year. In the summer of 2012, a citizen petition signed by more than 30 leading pain-addiction experts was sent to the FDA, asking for clarification and guidance to physicians on how to use extended-release painkillers. In the same time frame, the FDA released a Risk Evaluation and Mitigation Strategy (REMS) for a class of opioid medications, known as extended-release (ER) and long-acting (LA) opioid analgesics, used in pain treatments. In October of 2012 the FDA released a briefing on hydrocodone in anticipation of its Drug Safety and Risk Management (DSaRM) Advisory Committee meeting, and recently the FDA released a draft guidance relating to the development of abuse-deterrent opioids.

According to a recent report by the Substance Abuse and Mental Health Services Administration (SAMHSA), “prescription drug misuse is second only to marijuana as the nation’s most prevalent illicit drug problem, with approximately 22 million persons nationwide initiating nonmedical pain reliever use since 2002.” Officials are looking for inventive ways to combat this growing problem, and New York City has created a task force to tackle prescription drug misuse. According to the Partnership for Drug Free America, this initiative began in December of 2012 after officials identified 21 pharmacies that account for about one-fourth of the city’s oxycodone Medicaid reimbursements.

On January 10, 2013, New York City Mayor Michael Bloomberg announced that under a new city policy, emergency departments: (1)  will not prescribe long-acting opioid painkillers; (2) may prescribe no more than a three-day supply of opioids; and (3) will not refill lost, stolen or destroyed prescriptions. According to Deputy Mayor Gibbs:

“Changing practice by front line providers is key to changing the course of this epidemic…While prosecutors and the law enforcement community rightly focus on those who illegally prescribe, dispense or procure painkillers, health leaders need to focus on encouraging well-meaning doctors and pharmacists to prescribe and dispense these medications safely and judiciously. Our work will proceed on all fronts to curtail the harms that come from painkiller misuse.”

The mayor also released the new task force’s interim report on prescription pain killer abuse. The report noted that under new legislation, by the end of 2014, physicians will only be able to prescribe controlled substances electronically, which will circumvent the problem of forged prescriptions written on stolen prescription pads. The report also discussed a proposed regulation, initiated by the task force that would “require specific training for providers who prescribe more than 100 morphine equivalent doses (MED) per day to any patient not receiving end-of-life or cancer-related palliative care.” According to the report, the city’s next steps include:

  • Make naloxone more widely available.
  • Petition the FDA to modify the labels of prescription painkillersContinue to promote clinical guidelines on preventing misuse of prescription painkillers.
  • Support creation of standards for prescription drug monitoring systems by the federal government that allow for linkages between states.
  • Promote disposal of excess opioid painkillers.
  • Implement a temporary system that would prevent prescription forms from being activated until a doctor confirms that he or she has received the prescription pads.
  • Introduce a new education campaign for public high school students and parents.
  • Expand access to and use of all effective treatments for opioid dependence.

At a recent conference in California, New York City’s Police Commissioner, Raymond Kelly, announced “Operation Safety Cap” where GPS-enabled “bait bottles” will be stocked in pharmacies within their supply of regular prescription drug supplies. In the event of a robbery or theft, the bait bottles could lead officials to “stash locations” in the city, where drug dealers are storing large amounts of stolen prescription pain pills.

It remains to be seen what effect these policies and programs have on the growing problem, but if they are successful, keep your eyes open for similar programs in cities across the United States.

Filed Under: Centers for Medicare and Medicaid, Drugs, Food & Drug Administration, HHS, Medicaid, News, State Level

Fate of Generic Drugs in India Awaits High Court Ruling

January 16, 2013 by

According to a recent Washington Times article, the fate of India’s $26 billion generic drug industry is awaiting a ruling by India’s Supreme Court early this year. India, which produces much of the world’s generic cancer, malaria, tuberculosis and AIDS drugs that are provided to poor countries, has been accused of ignoring intellectual property and causing Western drug companies to reconsider investing money in drug development.

The pending Supreme Court opinion centers around the Novartis drug Glivec, a cancer fighting drug. Novartis attempted to patent a new form of the drug, giving it another 20 years of patent protection. Patient advocacy groups argue that the drug has not been substantially altered and that Novartis is “evergreening” in order to block generic access to the drug. Novartis has released the following statement about the pending decision:

The Glivec case is about gaining clarity on the application of patent law in India, which is important to the economic future of the country. Novartis challenged the decision not to grant a patent to our life-saving medicine Glivec because we strongly believe safeguarding incentives for innovation through the granting of patents leads to better medicines for patients. We also believe that working through the judicial system is a legitimate approach to gaining clarity on the unique aspects of India’s patent law. Novartis actively supports innovative approaches to increase access to medicines, such as public-private partnerships, tiered pricing arrangements and shared contribution models in addition to donation programs. More than 95% of all Glivec patients in India receive their medicine free of charge through the Glivec International Patient Assistance Program (GIPAP).

Doctors Without Borders, a secular humanitarian aid organization issued an open letter to Novartis and its CEO regarding the litigation, which states, in part:

India’s patent law has prevented market monopolies of Novartis’s cancer drug Gleevec and many other essential drugs, including those used to treat HIV. This has allowed generic competition to drive prices down and increase access to those that cannot afford the prices of patented medicines. In India, Gleevec costs over CHF 2,100 a month [about $2,180]; the generic costs CHF 170 [about $176]….. If you are successful, you will set a legal precedent and weaken the Indian patent law of much of its meaning. Because your actions will affect the supply of medicines—both in India and beyond, as Indian generics supply 80 percent of the HIV/AIDS medicines used in the developing world, to take just one example—we urge you to reconsider.

The implications of the court’s ruling have global implications on world health and drug development.  Stay tuned for further news as it develops.

Filed Under: Drugs, Food & Drug Administration, HHS, News, Patents
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