On August 8, 2023, Axios reported (here) that the Pentagon began contracting with Valisure, a drug testing facility, to test the generic drugs that it is purchasing. On August 9, 2023, Bloomberg reported much the same thing in an article titled “Tainted Medicine Fears Spur Pentagon to Seek Outside Testing” (here; subscription required). Congress has been pushing for investigations concerning drug shortages, including those caused by quality compliance issues. In addition, Congress is asking the FDA why the Agency is allowing unapproved chemotherapy drugs to be imported into the U.S. to help relieve severe shortages caused, in part, by quality problems at a number of facilities that have applications approved in the U.S. but are having some issues with respect to compliance. In a December 7, 2022 article by Ed Silverman of STAT titled “FDA scolds company that raised red flags over impurities in many widely used medicines,” he discussed the problems that the FDA found in the analytical testing methods employed by Valisure related to nitrosamines.
When peeling back the onion to uncover the true issues underlying drug shortages, there are a number of things to consider, including whether other federal agencies really do not trust the FDA to monitor drug product quality in both foreign and domestic facilities. I think this is somewhat clear by the actions that other federal agencies have taken recently, even in the face of the FDA’s new inspectional authority and the fact that the Agency has ramped up its inspection programs to deal with the issues of non-compliance that can lead to quality problems and drug shortages. However, should the blame be totally shouldered by the FDA?
In the real world, we know that the number of facilities that the FDA must inspect (and potentially reinspect if there are significant issues uncovered) can outstrip the Agency’s capability. Thus, a riskbased approach to scheduling inspections is being used to help the FDA place its scarce resources where they are most needed, and that translates into more frequent inspection of firms with perhaps not the best historical record of compliance. Mutual Recognition Agreements that permit the Agency to rely on the inspections of other regulatory bodies do lessen the pressure on the FDA to conduct some inperson inspections. But, in my opinion, the main problem that is not really being addressed by Congress is its failure to provide the Agency with the resources needed to permit the FDA to ensure the quality and safety of all approved drugs, OTC drug products, and the multitude of dietary supplements on the market, as well as unapproved or misbranded drugs that have found their way into the U.S. supply chain through nefarious means.
Perhaps it is time for Congress to step up to the plate and not only ask the FDA what the Agency needs to do its job but also provide a level of funding for it to do so! I know that this is a rather simplified view of how to solve the problem, but it seems to me that if Congress is so concerned about drug shortages and assurances of product quality, and if other government agencies are concerned enough to hire an outside testing firm to provide such assurances, then something is way out of kilter. Yes, throwing money at a problem is not always the best approach; however, the FDA has stateoftheart analytical testing capabilities, if only it had the funds to perform more random testing of products being distributed in the U.S. If the FDA had an inspectional force that could handle the large number of domestic and international inspections that must be conducted (both forcause and surveillance), then maybe confidence in the quality of our drug supply would improve. This would build on the Agency’s drug surveillance programs, allowing for an increased number of inspections as well as product quality testing. Yes, uncovering the “bigger than life” issues surrounding drug shortages caused by compliance problems or issues such as the of discovery of nitrosamine impurities, which has caused consternation among drug manufacturers worldwide, resulting in drug shortages, recalls, and delays in approval of a myriad drug applications, should be a wake-up call. But the call needs to be answered by Congress in terms of providing sufficient resources for the Agency to do what Congress wants it to do!
