Watchdog Urges FDA Reform Following Commissioner’s Resignation

FOR IMMEDIATE RELEASE

Contact: Kara Zupkus (224) 456-0257

WASHINGTON, D.C. – Today, the Taxpayers Protection Alliance (TPA) welcomed reports that Food and Drug Administration (FDA) Commissioner Marty Makary is resigning. Makary has come under fire from President Trump in recent weeks for refusing to approve safe and effective medications and holding back life-saving harm reduction products such as vapes.

Ross Marchand, Executive Director of the Taxpayers Protection Alliance, offered the following comment:

“At long last, Makary is out. Since taking the helm of the agency last April, the Commissioner has made it far more difficult than it needs to be to bring new therapies to market. Millions of Americans have paid the price for this soap opera of suddenly spurned approvals, goalpost shifting, and even apparent violations of trade secret law. It’s time to finally turn the page on this sorry chapter at the FDA.

“The data is clear: the FDA is approving medications even more slowly now than it did before. As TPA noted in its recent report, the FDA has become far more likely to issue Complete Response Letters (CRLs)—or rejections—for new therapies. Agency rejections have soared as a share of agency approval decisions and are now near decade highs. Meanwhile, the FDA under Makary has continued de-facto prohibition on harm reduction products. It shouldn’t have to take the White House pressuring the FDA Commissioner to side with patients and consumers over bureaucrats.

“Makary is finally gone, but the new Commissioner cannot be complacent. The FDA needs a leader who will stand up for patients and allow access to new and innovative therapies. Makary’s successor must embrace market innovation and break with the prohibitionary policies of the past.”

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The Taxpayers Protection Alliance (TPA) is a non-profit, non-partisan organization dedicated to educating the public through the research, analysis, and dissemination of information on the government’s impact on the economy.