While I applaud the administration’s determination, I am concerned that its plan ignores the main cause of drug shortages:with Bloomberg News that the administration wants to “Address the market failure that currently exists, which is that there is no entity that's accountable to supply chain. Today, when we have a drug shortage, various entities within the healthcare system point to each other.
Unfortunately, there’s a big disconnect between the frequency of quality problems that trigger FDA recalls and the agency’s stand on generic drug quality. Although the FDA does little product testing—opting instead to review company-supplied paperwork and occasionally inspect plants—the FDA’s Office of Generic Drugs’have the same high quality, strength, purity, and stability as brand-name drugs.
Dr. Ricardo Martinez, who led NHTSA from 1994 to 1999, explained the agency’s philosophy to me this way: “From the perspective of enhancing safety, the more the consumer knows about the safety performance of vehicles, the greater the market competition for safety. And NHTSA just doesn’t allow vehicle manufacturers to certify their compliance with federal regulations, it has the authority to pull any vehicle produced and test it for compliance.
In the coming months, findings from the U.S. military’s pilot drug testing program may start rolling out. When they do, the FDA’s insistence that “all generic drugs have the same high quality” may become untenable.