Trump Wants to Cut Regulations by 75%
On his first official working day in office, president Donald Trump has pledged to “cut regulations by 75%, maybe more.” Without releasing any details, particularly how it may apply to FDA and its regulated drug, biologic and medical device industries, Trump did say there will still be government regulation, “and it’ll be just as strong and just as good and just as protective of the people as the regulation we have right now. The problem with the regulation we have right now is that you can’t do anything.”
In another move that impacts FDA and industry, Trump signed an executive order to withdraw the U.S. from negotiations under the Trans-Pacific Partnership, which should also kill negotiations under the complement Transatlantic Trade and Investment Partnership (TTIP). Under TTIP, FDA and the European Union were moving forward with a GMP inspection mutual reliance agreement to recognize each other’s inspectional activities. There were still a number of issues that were being discussed between the parties, such as the scope of the provisions and operational implementation, according to a TTIP report.
Recent negotiations covered the scope and definitions under the agreement, and the exchange of confidential information between regulators and regulatory cooperation. “As in the previous round, the EU reiterated the importance of agreeing on solid regulatory cooperation provisions,” the report said. On medical devices, an EU proposal for an annex and a U.S. proposal were discussed in detail, according to the report. “The EU text comprises the main elements discussed with the U.S. during the previous TTIP negotiation rounds (the unique device identification, the regulated product submission and a place holder on the single audit of quality management systems),” it said. “The EU text proposal contains additional elements which have not been discussed under the TTIP in the past but the EU considers important from a regulatory perspective, namely cooperation on exchange information on non-compliant medical devices and cooperation on standards. The EU and the U.S. proposals for an annex on medical devices have been put side by side in order to identify commonalities.”
However, there is still hope that FDA could continue the mutual reliance activities for inspections under a different path. In a December FDA Voice blog post, FDA associate commissioner for global regulatory policy Dana Corrigan said mutual reliance could also take another path if the initiative progresses more quickly than the trade negotiations.”