Trump Expected to Bring Big Changes to FDA
[Analysis by Jim Dickinson and David McFarland] Notwithstanding president-elect Donald Trump’s failure to publish a written policy platform, objective assessments of his public statements lead us to expect major changes in the way FDA does business with its regulated industries after his administration takes over in January. Actually, nothing we could find on the Internet suggests that Trump is even aware of FDA’s existence.
If in governing President Trump were to seek guidance from the Republican Party platform — new White House administrations frequently make short shrift of their party’s platform — he would find a roadmap. Pledging to reform FDA, that document says FDA is now threatening “America’s leadership in life sciences R&D and medical innovation” through a “lack of predictability, consistency, transparency and efficiency … that is driving innovation overseas, benefiting foreign, not U.S., patients.”
The platform says FDA “has slowly but relentlessly changed into an agency that more and more puts the public health at risk by delaying, chilling, and killing the development of new devices, drugs and biologics that can promote our lives and our health.” It calls for leadership “that can reform the agency for our century and fix the lack of predictability, consistency, transparency and efficiency at the agency. The FDA needs to return to its traditional emphasis on hard science and approving new breakthrough medicines, rather than divert its attention and consume its resources trying to overregulate electronic health records or vaping.
“We pledge,” it continues, “to restore the FDA to its position as the premier scientific health agency, focused on both promoting and protecting the public health in equal measure, so we can ensure that Americans live longer, healthier lives, that the United States remains the world leader in life sciences and medical innovation, that millions of high-paying, cutting-edge device and drug jobs stay in the United States, that U.S. patients benefit first and most from new devices and drugs, and that the FDA no longer wastes U.S. taxpayer and innovators’ resources through bureaucratic red tape and legal uncertainty.”
Absent the quixotic Trump’s own thoughts on FDA, a reading of the tealeaves of his public statements and juxtaposing them with his anti-establishment campaign theme bodes ill for such establishment-favored and venerable FDA conventions as regulating off-label promotion, blocking Internet trafficking of prescription drugs from foreign pharmacies, keeping financially compromised and politically and religiously motivated “experts” off advisory committees, and holding drug and medical device manufacturers to regulatory R&D and production manufacturing standards that may be deemed “esoteric.”
Indeed, those statements and Trump’s frequent vows to “drain the swamp” in Washington strongly suggest a predisposition to dismantle existing regulatory infrastructures that don’t directly protect “public safety” (a term he has not defined).
In FDA’s case, as in past political transitions, expect the Trump Administration’s reform to begin at the top, with the routine resignation of commissioner Robert Califf, along with those of all other Obama appointees. Only once has a commissioner survived this process — Republican appointee David Kessler in 1993 when the Clinton Administration took over from George H.W. Bush’s.
Califf has been in office for only nine months, having survived a contentious confirmation process where many were concerned that his previous ties with industry while at Duke University should have disqualified his nomination. “During his tenure at Duke University, Califf racked up a long history of extensive financial ties to multiple drug and medical device companies, including Amgen, AstraZeneca, Eli Lilly, Johnson & Johnson, Merck Sharp & Dohme and Sanofi-Aventis, to name a few,” the Public Citizen said at the time. “Strikingly, no FDA commissioner has had such close financial relationships with industries regulated by the agency prior to being appointed.”
During Califf’s confirmation process, he was faced with more opposition from Democrats because of the industry ties, but during hearings before the Senate committee that vetted him, he seemed to garner stronger support from Republicans. As commissioner, Califf has attracted industry support, so it remains to be seen whether a Trump administration will accept his resignation.
Since Kessler’s voluntary departure, FDA has become an increasingly politicized federal agency, especially during the second Bush Administration. One measure of this has been the agency’s increased hiring of key personnel direct from regulated industry — a practice historically verboten, but now embraced by an expertise-hungry FDA sanctioned especially by Republican administrations. Conflict of interest concerns about such recruits, fanned by activist critics like Public Citizen, remain a red light, but the agency has been inventive in finding ways around them. Trump’s history in business management provides few clues as to such practicalities, but his campaign for the White House demonstrated an acute sensitivity to apparent conflicts of interest in Hillary Clinton’s during and after her tenure as Secretary of State.
Then there’s the issue of FDA’s traditional independence from politics in the approval of new products. Until the dying days of the Clinton Administration in 2000 when FDA approved the abortion drug RU-486 in a hurry lest the incoming Bush Administration get a chance to block it, the agency had never had a politically impelled drug approval. That soon became a big issue when the new administration vainly fought efforts in New York federal court to overcome its clandestine directives that FDA not approve the nonprescription morning-after contraceptive, Plan B. It would take six years to release the drug.
For the medical device industry, AdvaMed says its members will be dealing with a number of important policy issues under the Trump Administration, including authorization of the latest Medical Device User Fee agreement to continue improving the FDA regulatory process, repeal of the medical device tax, and ensuring that the coverage process allows patient access to the latest innovations. “The medical technology community stands ready to work with President Trump, his administration, and the new Congress on pro-innovation policy solutions to address the health care challenges facing the country and to ensure all Americans have timely access to the latest medical technologies, devices, and diagnostics,” the group says.
And both drug and device industries could benefit during the upcoming lame duck session of Congress if lawmakers decide to fast-track approval of the 21st Century Cures legislation that has made its way in companion bills through both the House and Senate (see related story). That, of course, would still be hostage until January to President Obama’s veto, since its FDA provisions are seen by Democrats as potentially damaging FDA product review standards in the pursuit of faster approvals. Waiting until after Trump’s inauguration might be a prudent option.
Trump’s public comments over the years, although not addressing FDA issues, strongly suggest an anti-regulation bias generally that could easily impact FDA in the future. And given his vows to act expeditiously, if not on “day one,” that could be sooner rather than later.