The cherry blossoms are done, but for some reason, the tourists are still sticking around Washington. The Administration continues to fill jobs, though frankly not at a fast enough rate, with the Secretary of HHS still unconfirmed as is the new appointment of Dr. Margaret Hamburg to FDA, which is sorely needed as the agency continues to meander under the appointment of yet another acting commissioner, Dr. Joshua Sharfstein. In fact, so much has happened this week that it is hard to report on it all. I am just going to pick out a few of the many, many things that caught my eye.
- FDA Reverses Itself on Painkillers – In a classic case of acting before thinking, the FDA reversed an earlier decision to pull some unapproved narcotics from the market. On March 31, the agency released news that it had taken action to halt the marketing of 14 unapproved narcotic drugs that were being manufactured and distributed. At the time, the release contained the following quote from Deborah M. Autor, J.D., director of CDER's Office of Compliance. "Today's warning letters are another demonstration of our commitment to remove illegal, unapproved drugs from the market." (Ooops Number 1). Turns out these drugs are essential to patients in hospice receiving palliative care. The FDA sent out the Warning Letters because they can, without thinking about whether or not they should – at the expense of those in hospice (sort of like the 14 letters from last Friday regarding search engine ads). And if anyone has noticed, the FDA has not been approving ANY painkilling drugs because they haven't figured out a methodology to explain what a Risk Evaluation Mitigation Strategy (REMS) program would be for painkillers. (That is Ooops Number 2). In the March 31 release, the agency named the names of all the companies that received Warning Letters. Then the FDA was made to realize their error and reversed course with respect to 20 mg/ml morphine sulphate oral solution and sent out a new release taking back some of the action. Unfortunatley, their release did not name the names of the companies who are manufacturing it even though they named the names of the companies who received the Warning Letters. Doesn't exactly strike one as fair balance, does it? (Ooops Number 3)
- Joshua Sharfstein Urges Staff to Reform FDA – Bloomberg reported that Dr. Sharfstein sent a letter to FDA staff urging them to come up with short term ideas for improving the FDA. Certainly the quick action that FDA took on pistachios and the ways that it differed greatly from the approach on peanuts by acting before people became ill signifies a manifestation of some change. But the 14 Letters fiasco and the story above demonstrate that there is a lot of work to do in order to have the agency enunciate policy consistently and appropriately.
- Genentech Announces Voluntary Withdrawal of Raptiva – Genentech announced withdrawal of Raptiva, a treatment for psoriasis, from the U.S. market due to concerns about the possibility of progressive multifocal leukoencephelopathy (PML). PML is a horrible disease of the central nervous system that, while rare, has been an adverse event associated with other drugs and became more common during the days of the AIDS epidemic, prior to treatment with antiretrovirals.
- FDA To Review Devices From Prior to 1976 – Old devices are going to get scrutinized by FDA for safety and effectiveness. Specifically, manufacturers of 25 types of medical devices marketed prior to 1976 must submit safety and effectiveness information to the agency so that it may evaluate the risk level for each device type. Devices found by the FDA to be of high risk to consumers will be required to undergo the agency’s most stringent premarket review process. Not exactly timely, but a comfort I guess.
That's it for me this week. Have a good weekend everyone.
