FDA’S SOCIAL MEDIA Guidelines
The FDA finally released some actual guidelines on social media. Granted, it isn’t much, but after two years of waiting (since the 2009 FDA hearing on the topic), it’s better than nothing. The actual title of these guidelines is “Responding to Unsolicited Requests for Off-Label Information about Prescription Drugs and Medical Devices,” and it is merely an update to previously released guidance on this subject, except that the agency makes its first mentions of “emerging electronic media” with specific call-outs to YouTube and Twitter (http://1.usa.gov/sJFb2q). Here are some electronic media-specific highlights:
Brand Name: It is the company’s choice whether to respond to an unsolicited request, but it should only respond if its specific brand is mentioned.
Science Only: Responses to unsolicited requests should be “scientific in tone and presentation,” and should come from medical or scientific personnel and not sales and marketing personnel.
Private, Not Public: Even questions that are posed in a public forum should be answered in a one-to-one communication. The FDA does not want information about off-label use to remain on a site for all to see for an extended period of time. Instead, a company should supply the contact info for medical or scientific personnel whom the interested party can contact individually.
Non-Promotional: A public response should not include any promotional materials, such as product websites, company websites, or third-party websites. A link to the current FDA-required labeling, however, should be posted.
Don’t Solicit: Some of the things the FDA considers to be soliciting: Tweeting results of a clinical study revealing that an off-label use may be safe. Encouraging users to post videos about using their product on a third-party site, such as YouTube, if the solicitation results in a post about off-label use. Sending information about off-label use to bloggers or online consumer reviewers and encouraging them to write about it on third-party websites. —Andrew Matthius
ANTI-INFECTIVE DRUG SHORTAGES
A recent report in Clinical Infectious Diseases reviewed the growing trend of anti-infective drug shortages, which poses a serious threat to public health and patient care. The authors, led by Marc Scheetz, PharmD, and Milena Griffith, PharmD, from Midwestern University Chicago College of Pharmacy and Northwestern Memorial Hospital in Chicago, found that of the 193 medications unavailable in the U.S. during their analysis, 13% were anti-infective drugs.
This can be a major problem. The authors note that “anti-infectives often represent irreplaceable life-saving treatments,” and the drugs are used as first-line treatment for diseases such as herpes encephalitis, neurosyphilis, tuberculosis, and enterococcal infections. The problem is exacerbated as the frequency of anti-infective shortages continues to grow and the approval of new anti-infectives from the FDA has slowed down.
The root cause of shortages could not be determined, since U.S. law does not require drug manufacturers to disclose the reason for shortages. Some commonly named culprits included lack of raw materials, regulatory compliance violation halting manufacturing, product contamination, market shortage due to epidemic, perceived shortages resulting in unnecessary stockpiling, business decisions to cease production due to the availability of therapeutic alternatives, reallocation of resources, and other financial reasons.
The authors believe more oversight from the FDA may be necessary to identify and correct these shortages. There is currently legislation making the rounds that addresses this issue. The Preserving Access to Life-Saving Medications Act of 2011, which was introduced and referred to the House Committee on Energy and Commerce, Health Subcommittee in June 2011, would amend the Food, Drug, and Cosmetic Act by requiring manufacturers of prescription drugs to notify the FDA six months before halting or interrupting production or of any manufacturing changes that could potentially lead to a shortage. —A.M.
A Helping Hand
Last month, the National Institutes of Health (NIH) officially opened its new center dedicated to helping reduce, remove, or bypass those many bottlenecks that obstruct the translational pipeline. The ultimate goal of the newly established National Center for Advancing Translational Sciences (NCATS) is to help get new drugs, diagnostics, and medical devices to patients faster. National Institute of Mental Health (NIMH) Director Thomas Insel will serve as acting director while a search is underway for a permanent director.
Though NCATS is new in name, it was primarily formed by realigning existing NIH programs. Also, since the NIH by law can have only 27 institutes and centers, one of its previous components had to be dissolved to make room. The National Center for Research Resources (NCRR) was split apart, and its programs were distributed throughout the rest of NIH. One of NCRR’s biggest programs, the Clinical Translational Science Awards (CTSA), will be the heart of NCATS. When Congress approved the fiscal year 2012 spending bill, NCATS was allotted $575 million, with $487 million dedicated to CTSA. The only money Congress approved for new programs was $10 million for the center’s Cures Acceleration Network (CAN)—NIH Director Dr. Francis Collins originally asked for $100 million.
The purpose of CAN is to fund the advanced research and development of high need cures and get them through the development pipeline faster. NCATS’ other programs include: Bridging Interventional Development Gaps (BrIDGs), FDA-NIH Regulatory Science, Office of Rare Diseases Research (ORDR), Components of the Molecular Libraries, and Therapeutics for Rare and Neglected Diseases (TRND).
According to ScienceInsider, NCATS will continue several initiatives begun last year, including finding new uses for abandoned drugs (with the cooperation of pharma companies) and developing a chip for predicting drug toxicity. One thing the new center will not become is a drug development company—Congress stipulated that NCATS cannot fund late-stage clinical trials. —A.M.
FDA update
PHARMA
The FDA completed its recommendations for three user-fee programs to help speed the process of getting safe and effective drugs to patients. The recommendations for the fifth authorization of the Prescription Drug User Fee Act (PDUFA) include: fees paid by industry would support continued timely review of critical prescription drugs as well as advance the development of drugs for rare diseases; provide for enhanced communication with small or emerging companies; increase use of standardized electronic data to improve quality and efficiency; and foster use of new clinical endpoints that improve drug development times and help address unmet medical needs. The proposed new Generic Drug User Fee program would provide the FDA with needed funding at a time when generic drug applications are on the rise. The proposed Biosimilar and Interchangeable Products User Fee program is intended for products approved under a new abbreviated approval pathway for biological products shown to be biosimilar to or interchangeable with an FDA-licensed biological product.
The FDA has added a new boxed warning to Seattle Genetics’ lymphoma drug Adcetris (brentuximab vedotin). The risk warns of the possibility of progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection that can result in death.
Gilead Sciences announced that the FDA approved Viread (tenofovir disoproxil fumarate) in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients ages 2-12.
Novartis Consumer Health has voluntarily recalled all lots of select bottle packaging configurations of Excedrin and NoDoz products with expiry dates of December 20, 2014 or earlier as well as Bufferin and Gas-X Prevention products with expiry dates of December 20, 2013 or earlier, in the United States. The products may contain stray tablets, capsules, or caplets from other Novartis products, or contain broken or chipped tablets.
MEDICAL DEVICES Focus Diagnostics’ Stratify JCV Antibody ELISA test was approved as the first test to help determine the risk for a rare brain infection called progressive multifocal leukoencephalopathy (PML) in people using the drug Tysabri (natalizumab) to treat multiple sclerosis or Crohn’s disease. —A.M.
