New independent study blasts FDA safety enforcement

The New York Times has a mind-blowing report on the very serious systemic problems at the FDA agency, specifically in terms of their regulation of drug safety.

The article notes that according to a recent study by the well-respected, independent Institute of Medicine (part of the National Academy of Sciences), there are deep concerns about the federal agency’s “organizational health” as well as its ability to ensure the safety of the nation’s drug supply (one of its most important responsibilities).

Not surprisingly, the multi-billion dollar pharmaceutical industry, through its powerful lobbying army on K Street, was quick to cast aspersions on the independent study’s findings. Big Pharma, of course, very much likes the FDA’s enforcement regime the way that it is–that is, with the FDA doing the bidding of the lobbyists as opposed to, say, regulating them like it is supposed to.

According to the Times, the IOM study validates the key concern among many watchdog organizations and FDA critics that the agency is too intent on rapidly approving every new drug that comes down the pike that it is failing to ensure the safety of the drugs.

The article goes on to note that one of the FDA’s most serious problems originated in a deal struck back in 1992 between Congress and the drug industry in which drug makers “agreed to pay millions in fees to speed reviews.” This deal has increased pressures on drug reviewers to act quickly, and it has limited “the ability of reviewers to examine safety signals as thoroughly as they might like.” If this sounds like a recipe for disaster, that’s because it is.

Drug manufacturers create life saving drugs all the time, and I am all in favor of their being able to expeditiously get those products to market as quickly as possible. I don’t want to see a federal bureaucracy get in the way of the private sector innovating and helping cure diseases and illnesses. But the upshot of the IOM study is that a balance needs to be struck between protecting industry incentives and profits and protecting the health and well-being of American citizens who have little knowledge of how the drugs they are taking work and are reliant upon the federal government to ensure their safety. And the FDA’s current enforcement efforts are far out of balance in favor of industry.

This is something Congress should be acting upon immediately, but don’t expect the industry to let much-needed reforms to occur without a tough fight. And as the article makes clear, any changes aren’t likely to occur in the next year:

“There is little chance that Congress will act on any of these proposals before next year, when it must reauthorize the 1992 financing deal with the drug industry. Negotiations between the drug industry and agency about the parameters of that deal are already under way.”