Coalition Commentary by Executive Director John Kamp
Feb. 6, 2017 — Fasten your seatbelts and put your tray tables in their upright and locked position as you watch the Trump administration land on our industry.
At a recent White House meeting with PhRMA and industry CEOs, Trump made sure the cameras were rolling as he repeated his screed against drug prices and demanded that more drugs be produced in the United States. But, he later followed up by seemingly rescinding calls to negotiate Medicare drug prices and reimportation of drugs from abroad, and promising lower taxes and a “streamlined” FDA. The result is a mixed bag of good and bad for our industry.
Two recent executive orders and leaks about who might be appointed as head of the FDA have increased the anxiety of industry watchers on the future of drug approvals and the new rules needed to advance the goals of the recently passed 21st Century Cures Act.
The two orders that have rattled the industry are: (1) the freeze on federal hiring and (2) the requirement that two rules be rescinded for every new one created.
The FDA policy and approval processes are implemented by its staff, and because the FDA has hundreds of vacancies in the Center for Drug Evaluation and Research (CDER), the hiring freeze is especially troublesome. Indeed, it is not even clear if the freeze applies to new hires paid for by industry fees. A hiring freeze will chill approvals and the development of new policies intended to simplify and speed drug approvals.
Meanwhile, the two-for-one rule is particularly complicated at the FDA, where hundreds of policy decisions are announced through informal guidances that, according to White House representatives, are within the scope of the order.
Most unnerving to FDA insiders and industry policy veterans are the names of some of the possible nominees to be Commissioner of the FDA.
Four names have been mentioned for FDA Commissioner. All have been involved in healthcare startups, investments, and private-sector innovation, which may be a good sign, but several have ideas viewed as extreme by industry.
Two of the possible candidates are friends of Peter Thiel, Silicon Valley billionaire and Trump supporter, but lack the usual medical credentials. The first is Jim O’Neill, managing director of Mithril Capital Management, former deputy at HHS who has openly favored a multiple-step approval system under which drugs would first be approved for safety only. The second friend of Thiel is Balaji Srinivasan, partner at Andreessen Horowitz and CEO of 21.co, who is a fierce opponent of the current device approval process.
The other two potential choices are doctors. Joseph Gulfo, former CEO of device company Mela Sciences, is an outspoken opponent of the breakthrough approval process and favors a new evidence standard for approval. Scott Gottlieb, former FDA deputy commissioner, is a high-profile advocate for improvements at FDA and is the inside-the-Beltway favorite because of his experience at FDA and in lower-volatility positions.
In the face of all this, CDER head Janet Woodcock recently produced a staff video suggesting employees keep their heads down and focus on the work of the agency rather than on the uncertainty of the transition.
Brace yourself and stay tuned. The Trump team comes with high winds and crosscurrents. It looks like it’s coming in hot.