Washington Insider: Drug-Safety Legislation

When will the pharma industry resume working with Congress on drug safety?

Paul Thacker is a journalist and adviser to nonprofits.
Paul Thacker is a journalist and adviser to nonprofits.

I was discussing the approval of Sprout's female sexual-dysfunction drug, Addyi, with a friend, who wryly suggested, “It can make you pass out if you take it with alcohol. Maybe we should call it the ‘Bill Cosby.' ” 

Kind of ridiculous, no? But even worse is the drug's clinical study that tested alcohol's side effects with Addyi on 23 men ... but only two women. At least the FDA put a black box on the drug's label warning women about ­alcohol consumption.

Tiny victories for consumer safety, I guess.

A Forbes analysis of BioMedTracker data found that the FDA only rejects new drug applications around 11% of the time. This compares to a rejection rate of 66% of new drug applications back in 2008. Yet one of the latest bills passed by the House of Representatives is filled with language that seeks to strip the FDA of authority to reject drugs in order to “streamline” the approval process and get products on the market faster. 

Much of this language dances around certain diseases that are not high-enough priorities for the industry to address anyway, but creating this atmosphere of “approve, approve, approve” at the FDA ensures that drugs will slip through the process.

In our rush to get any and all drugs on the market, what can we expect on the horizon? 

I predict that within 10 years we will see the pharma industry begin working with Congress to address the increasing number of media reports of “dangerous drugs” that are harming the American public. This will most likely involve new drug-safety legislation because we know that industry has a history of “fixing” problems that a forgetful public doesn't realize were created by industry itself.

To be clear, we need products that help patients deal with illness. But we can't sacrifice safety just to help companies report better earnings on Wall Street.

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