With safety woes found in 1 in 3 approved drugs, does a faster FDA make sense?

IMG_1029-300x201Although critics—including the agency’s incoming chief—want the federal Food and Drug Administration to speed its approval processes for prescription medications, new research shows there can be significant risks in a go-go-go approach to Big Pharma oversight. Experts at Yale Medical School have found that a third of the drugs that hit the market with FDA approval between 2001 and 2010 suffered major safety issues that were only found after the medications became publicly available.

Of 222 drugs scrutinized by researchers, 71 were withdrawn or required public announcements about their previously undiscovered risks, including some that were slapped with “black box” warnings—one of the FDA’s most stern indicators a medication carries significant side effects.

The authors of the study, published in the Journal of the American Medical Association, said the drug approval process is imperfect, and it can frustrate many because it can be time-consuming, taking years for a medication to go from lab bench to bedside.

But even with the current, multi-step process, in which many drugs must undergo animal and human clinical trials, it can take roughly four or so years more before further safety issues arise with approved products, the researchers said. They noted that safety concerns developed more often with drugs that get the green-light near deadlines for them to do so, and those that received expedited consideration.

Whether the FDA speeds its current drug approvals or not, the researchers cautioned regulators and policy-makers that, to protect the public, monitoring and oversight of medications’ effects, risks, and benefits must be long and sustained.

The researchers’ warnings were published even as the Senate confirmed Scott Gottlieb as President Trump’s new FDA chief. Gottlieb, 44, is a physician with deep Big Pharma ties, including as an investor and venture capitalist. Lawmakers, in their 57-42 confirmation vote, expressed worry whether his many declared conflicts of interest will make him ineffectual or keep him too deeply in the industry’s thrall.

Gottlieb has pledged to recuse himself for a year in participating in FDA oversight of any business or interests to which he has previous ties. That list already is long, and new disclosures already have popped up, including his investment in an e-cigarette manufacturer, for which he also served as a board member.

Although the new FDA head’s conflicts have raised eyebrows, lawmakers, his opponents, and even Big Pharma itself may have been relieved that Gottlieb, who served in the George W. Bush Administration, has experience and knowledge in the areas his agency will oversee. The Trump Administration had floated other candidates—Silicon Valley venture capitalists with scant, proven expertise in biomedical science and medicine.

In my practice, I see the harms that patients can suffer due to dangerous drugs. The FDA, in my view, needs serious reform and greater clarity in its mission to serve and protect the public. Although Big Pharma, with cost and profit concerns always at the fore, has pushed the view that Gottlieb and the Trump Administration have adopted that Uncle Sam should hurry up its drug approval process, other research shows that comparable oversight by the Europeans and British is less speedy than ours.

We need to act with moderation so risky products aren’t raced to market to seriously harm patients, as has occurred, while lifesaving medications also aren’t stalled in deadly bureaucracies.

The Administration also would serve the American public well by responding not just to Big Pharma’s issues but also keeping a sharp focus on the safety, accessibility—and, of course, the cost of drugs. As Stat, the health and medicine site, has reported: Drug “prices rose 8.8 percent last year, which is the fourth consecutive year of overall price hikes that exceeded 8 percent …. Moreover, this amounts to an annual average price increase of almost 10 percent over the past three years. By comparison, the consumer price index rose 2.1 percent in 2016.”

Yes, America should produce cutting-edge, innovative new therapies to change and save lives. But if patients can’t afford what we have now, there’s lots of work for all of us to do, right?

Patrick Malone & Associates, P.C. listed in Best Lawyers Rated by Super Lawyers Patrick A. Malone
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