Trump Promises to "Reform the FDA" in Post-Election Mission Statement

November 11, 2016
By Mark Terry, BioSpace.com Breaking News Staff

The President-Elect Donald Trump Administration has a new website with a .gov suffix, greatagain.gov, and has updated —sort of—Trump’s intended policies for healthcare and biopharma.

First off, the website indicates its plans to repeal the Affordable Care Act (ACA), saying, “A Trump Administration will work with Congress to repeal the ACA and replace it with a solution that includes Health Savings Accounts (HSAs), and returns the historic role in regulating health insurance to the States.”

It then goes on to mention six points that aren’t necessarily clear, such as “Protect individual conscience in healthcare.”

It does say it will “Advance research and development in healthcare,” and in a line that is likely to make biopharma pay attention, if not necessarily happy, “Reform the Food and Drug Administration, to put greater focus on the need of patients for new and innovative medical products.”

John Carroll, writing for Endpoints News, says, “Nowhere in that list of healthcare priorities is there so much as a mention of drug prices, which had figured prominently in Hillary Clinton’s campaign. And those two features—promising to push development and speed approvals while staying mum on prices—helped create the impression among investors that the industry would be advantaged by a Trump administration. Or at least the new administration would likely leave it in a more favorable position than Clinton would have created.”

At one point in his campaign, Trump suggested that he would allow cheaper drugs manufactured abroad to be sold in the U.S. It’s nothing mentioned in his recent website and isn’t something he’s discussed much or at all since. There was also mention early on about allowing Medicare to negotiate drug prices, but that’s not on the website either.

Carroll speculates that the Republicans will likely try to pass the 21st Century Cures Act, now that they control both houses of Congress and the White House. There are many things in it that biopharma likes, and perhaps in contrast to Trump’s point about FDA reform, it’s been favored by Janet Woodcock, director of the U.S. FDA’s Center for Drug Evaluation and Research (CDER).

One thing the bill proposes is increased funding for the National Institutes of Health (NIH) and clinical research. But it also proposes changes to how drugs are approved, increasing the use of surrogate markers. Forbes notes, “Monitoring biochemical markers as a stand-in for disease progression has been useful for hepatitis and HIV treatment, but has been disastrous in other areas, like statins, diabetes, oncology and hormone replacement therapy.”

It also appears to weaken safety regulations for medical devices, but also make experimental drugs more available to patients—which brings its own set of complications both ethically and financially, for biopharma companies involved in clinical trials.

In terms of repealing the ACA, although Senator Mitch McConnell and Speaker of the House Paul Ryan have indicated agreement with President-elect Trump on doing this as quickly as possible, most policy experts and healthcare economists believe it will be much more difficult than a stroke of a pen. One, it’s pretty much political suicide to take health insurance away from 20 million people. President Trump may not care, but most senators and representatives do.

Avik Roy, co-founder and president of the Foundation for Research on Equal Opportunity, writing for The Incidental Economist, and Forbes said that if “repeal and replace” is the plan, they will likely start with partially repealing using reconciliation, “with the subsidies expiring in 2019,” and then the Republicans working out some sort of compromise deal with the Democrats “on a pathway to market-based universal coverage that reduces, instead of increasing, the federal role in health care.” And finally, he suggests that this two-year window could be replaced by a “system of means-tested tax credits. There are likely to be 60 votes for the Obamacare replacement under this scenario, because once Obamacare’s subsidies have been repealed, Republicans will have negotiating leverage with Democrats who would prefer a more statist approach.”