The much-criticized U.S. Food and Drug Administration is under fire again on two fronts.
On one front, critics charge the FDA with unnecessarily drawing out the process of testing and certifying new drugs for release on the general market.On the other, an investigation has disclosed how lax the FDA has been in regulating the generic drug industry.
Generic drugs are copycat drugs, supposedly indistinguishable except by price from brand name drugs. The investigation disclosed that many generic drug makers either bribed FDA regulators or submitted false information about tests on their products to get them approved.
Some 250 generic drugs were recalled when the scandal came to light and an independent commission was appointed in February to investigate and make recommendations.
Now the commission's report is in, and it calls on the FDA to tighten its regulation of the generic drug industry, taking measures ranging from stricter standards for generic drugs to heavy civil penalties and fines for firms violating the regulations. Individual violators would be barred from participating in the drug industry.
According to the FDA, some of the recommendations have already been implemented by the agency and the rest will be studied.
While the commission's findings may solve one of the FDA's problems, the other remains untouched.
Drug firms spend billions of dollars and years of laboratory research developing new medicines before one is submitted to the FDA for approval for use by the public.
The FDA typically takes several more years to run its own tests, usually duplicating the ones already done by the researchers. Up to a point, the FDA's caution is understandable. The trouble is that the FDA takes considerably longer than do similar agencies in other industrialized countries, particularly in Europe.
The result is drug companies with a huge investment in a product that is held off the marketplace for several more years. In some instances, widespread suffering and even deaths occur while potentially helpful drugs are withheld for redundant laboratory testing.
The approval process needs to be streamlined, perhaps through a two-tiered review process.
Products submitted for approval could be subjected to briefer, less time-consuming analysis, spot checking the research data included by the firm as the basis of the tests.
At the same time a certain number of applications, maybe one in 10, could be picked at random and subjected to more extensive testing. The random picking of products for full-on testing would ensure that drug firms not slack off on their own research or fudge on their findings in hopes of getting a product on the market that isn't fully tested.
The FDA has become a bottleneck in medical research and development and needs to streamline the way it operates.