- Another tool helping developers navigate the difficult road to approval of drugs for rare diseases (blogs.fda.gov)Rare Diseases: Common Issues in Drug Development Guidance for Industry (fda.gov)
...there are roughly 30 million Americans who suffer from a rare disease. And sadly, about 50% are children.. FDA…recently released a new resource for drug developers — a draft guidance document — designed to help them navigate the difficult and unique challenges of developing and bringing to market…drugs to treat rare diseases...document is intended to encourage drug developers to think early on in the process about all aspects of their program — and encourages careful planning which includes a foundation in strong science. Drug developers for rare diseases are often pioneers…this guidance as another important resource to help support their efforts.
- The Promotion of Medical Products in the 21st Century – Off-label Marketing and First Amendment Concerns (jama.jamanetwork.com)
On August 7, 2014, Federal District Court …blocked the Food and Drug Administration from enforcing restrictions on the marketing and promotion of off-label use of the drug icosapent ethyl (Vascepa),..If the case heralds the future of jurisprudence, responsibility for the oversight of the truthfulness of pharmaceutical promotions may shift from the nation’s leading science-based regulatory agency, the FDA, to the courts. If it does, the market for medications in the 21st century may revert to a time of more claims and less evidence to guide clinical care… Judges should refrain from using the First Amendment to undermine core regulatory functions.
- Pacira sues FDA over pain drug marketing restrictions (reuters.com)
Pacira Pharmaceuticals Inc….filed a lawsuit seeking a court order allowing it to promote its post-surgery pain drug, Exparel (bupivacaine), for a wide range of surgeries, which the Food and Drug Administration opposes…Pacira contends that its own marketing is not for off-label use…Exparel,… is approved for administration into the site of surgery to produce post-surgery pain relief…approval was based on studies of its use in bunionectomies and hemorrhoidectomies,…Pacira, however, has promoted it for use in all kinds of surgeries.
- Pfizer’s quit-smoking drug not linked to depression or heart risks (reuters.com)
Pfizer's stop-smoking drug Chantix (varenicline) does not raise risks of heart attack or depression, contrary to previous reports, and should be recommended to more smokers wanting to quit, scientists said…researchers found that patients who took Chantix,..marketed as Champix in Europe, were no more likely to suffer a heart attack than those using nicotine replacement therapy or another quit-smoking drug…also not at higher risk of depression or self-harm...
- New aspirin formulation gets FDA approval for secondary prevention of stroke, cardiac events (formularyjournal.modernmedicine.com)
FDA has approved aspirin extended-release capsules (Durlaza)for the prevention of stroke and acute cardiac events…is the first, and only 24-hour, extended-release aspirin capsule…allows prolonged absorption and sustained platelet exposure to aspirin…indicated to reduce the risk of death and myocardial infarction in patient with chronic coronary artery disease,...
- An Age-Old Battle: The FDA Versus the Shill (theatlantic.com)
The kerfuffle over Kim Kardashian's drug-promoting Instagram selfie is nothing new: As long as the agency has existed, it's had to figure out how to regulate drug advertisements in new forms of communication technology…The rise of social media has raised a parade of new questions for the agency: How is it supposed to monitor person-to-person pharmaceutical recommendations? Can something be considered an advertisement if it’s only 140 characters long? Who is responsible for the accuracy of tweets about a drug? But this isn’t the first time evolving technology has forced the FDA to rethink its role.
- IACP Submits Comments on FDA’s Underestimated Time & Cost Burden of Reporting 503B Adverse Events (iacprx.org)IACPodcast 19 - FDA Guidance on 503B Facilities (iacp.site-ym.com)
International Academy of Compounding Pharmacists submitted comments on the Food & Drug Administration's underestimated time and cost burden of reporting adverse events by 503B outsourcing facilities.
- Advera Health Analytics: Merck statins linked to more muscle side effects than rest of class (fiercepharma.com)
Statins are tried-and-true moneymakers, but they also come with their own set of safety concerns…FDA postmarketing safety reports… on side effects for companies producing statin drugs…found that Merck's Zocor, Mevacor and Vytorin were associated with more muscle-related side effects than other drugs in the class…For example, Zocor had 4275 reports of myalgia, 632 reports of myopathy, and 3552 cases of rhabdomyolysis..
- FDA Looks to Develop Regulatory Strategies for Genomic Testing (raps.org)
Food and Drug Administration is working to develop regulatory systems for diagnostics using next generation sequencing technologies…will cover "analytic performance evaluation standards" and "challenges in clinical validation of NGS tests."...We aim to ensure that these tests provide accurate, reproducible, and meaningful results relevant to a person's medical condition while continuing to foster innovation so that people who have access to the best available results generated by the most cutting-edge medical technologies."
- FDA staff flag likely dosing errors with Purdue’s opioid painkiller (reuters.com)
Food and Drug Administration…have expressed concerns over likely errors in administering Purdue Pharma's fast-acting oxycodone…(Avridi) that could result in inadequate relief…The drug is designed to be taken every 4-6 hours on an empty stomach…absorption…can be substantially delayed in the presence of food,.. "food effect" may reduce the effectiveness and safety of the drug,.. Inadequate pain control caused by presence of food could lead to overdosing…