America Desperately Needs a Much Better F.D.A.

And there is a lucrative reason to try to make it as a senior official at the F.D.A. — it could lead to a cushy second career as a consultant to the drug industry. The revolving door between the F.D.A. and the industry spins so fast we could tap it as a source of renewable power. Between 2001 and 2010, according to one study, 26 F.D.A. reviewers who worked on cancer and hematology drugs left the agency; more than half of them went on to work or consult for the drug industry. Scott Gottlieb, who ran the agency from 2017 to 2019, is now on the board of directors of Pfizer.

Earlier this summer I read “Empire of Pain” by Patrick Radden Keefe of The New Yorker, a superb and infuriating investigation of the Sacklers, the family that owned the company that made the powerful and addictive painkiller OxyContin. Keefe — building upon work by other journalists who’ve investigated the opioid epidemic, including by Barry Meier, a former New York Timesreporter — tells a riveting story of a family business driven by greed and willfully blind to its igniting role in an epidemic that killed nearly 500,000 Americans between 1999 and 2019.

Before reading Keefe’s book, I had been under the impression that the F.D.A.’s initial approval of OxyContin and its long neglect of the dangers posed by opioids was a routine story of regulatory mishap — that the agency got it wrong because drugs are complex and unpredictable and regulators aren’t perfect.

But Keefe makes clear the F.D.A.’s mistakes were worse than simple incompetence. The Sacklers’ company, Purdue Pharma, cultivated close relationships with key F.D.A. officials. Among them was Curtis Wright, the F.D.A. official who oversaw the process for OxyContin’s review. At times during the review process for OxyContin, Keefe writes, “it could seem that Wright had given up his role as impartial federal regulator and become a sort of in-house advocate for Purdue.” Within two years of leaving the agency, Wright went to work for Purdue.

Can the F.D.A. be fixed? Perhaps, but it would take rare political courage to enact reforms that might address the agency’s deepest problems, like its reliance on drug money to pay for its operations. Most of the political pressure on drug approvals runs in the direction of action — the pharmaceutical industry will always want to sell new products, and patient advocates tend to be desperate for new treatments even if there might be risks to safety.

Sometimes courageous scientists stand firm against these forces. In June, three F.D.A. advisers resigned in protest of the approval for aducanumab. On Tuesday the agency said that Marion Gruber, the agency’s vaccine director, and her deputy, Philip Krause, will soon leave the agency, reportedly in part because they were upset about the Biden administration’s recent announcement that Americans should get Covid-19 booster shots.

Author: diyg

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