Rx Drugs

Former FDA chief Scott Gottlieb warned that the federal government’s COVID-19 vaccine allocation plan could create access issues for underserved communities and older populations, and he urged officials to focus on mitigating any potential disruptions, including weighing how to help states set up mobile vaccination sites.

A leading pharmacy compounding group predicts that FDA might face lawsuits from states and compounding pharmacies over its final memorandum of understanding, which subjects compounding pharmacies located in states that don’t sign the MOU to a 5% sales cap on the amount of compounded product that can be shipped out-of-state.

FDA might allow COVID-19 vaccine makers to test the efficacy of their investigational vaccines against any vaccine that gains FDA approval, in a bid to help resolve ethical questions around placebo-controlled studies, although the agency continues to push for sponsors to use placebo-controlled trials for as long as possible.

An FDA advisory committee will vote Nov. 6 on whether to recommend that FDA approve the first drug to treat Alzheimer’s, and the Institute for Clinical and Economic Review already is planning the process of recommending a price for what might be a very expensive drug.

Community health centers on Wednesday (Oct. 21) sued HHS for not putting forward regulations for a dispute resolution process and, as such, depriving the providers of their only way to take drug makers to task for making them pay full price for drugs through 340B contract pharmacies.

A new World Health Organization-funded study that found remdesivir may not reduce mortality from COVID-19 could put pressure on its maker, Gilead, to cut the price of the antiviral, which is the only pandemic drug to receive an emergency use authorization.

FDA on Thursday (Oct. 22) will ask its vaccines advisors to consider whether COVID-19 vaccine sponsors should keep their phase 3 trials blinded even after an emergency use authorization is granted, coming as two of the leading vaccine developers, Pfizer and Johnson & Johnson, warn that if granted an EUA they might ethically need to unblind their studies to allow participants to access EUA vaccines or to cross over to the vaccine arm of a trial.

FDA has brought in seven temporary voting members to fill out its 17-member vaccines advisory committee, which will meet this Thursday (Oct. 22) to discuss general COVID-19 vaccine development and licensure or emergency use authorization data standards and policy issues.

The Supreme Court’s recent decision to punt back to a lower court a case over FDA’s in-person prescribing requirements for the abortion pill mifepristone has women’s health advocates, who oppose the requirements, on guard.