Pink Sheet: 世界の薬事規制と承認審査に関するニュース
By John Davis 31 Mar 2020
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the...
In meeting with PhRMA, president says FDA approval must be faster and that a commissioner pick is coming.
President Donald Trump promised to "streamline" FDA and signaled he was prepared to make changes at the agency during a Jan. 31 meeting with drug industry executives at the White House.
In a Jan. 31 meeting with industry executives and representatives of the Pharmaceutical Research and Manufacturers of America, Trump seemed to place at least some of the blame on FDA for the time needed for a new drug to reach patients.
He said that he was "focused on accelerating FDA approvals." He did not provide much detail on his plans, adding that "you can get your products either approved or not approved, but it's going to be a quick process."
He also expects to alter agency practice to increase approval speed. "We're going to be changing a lot of the rules," Trump said, arguing that there may be a way to increase protection for the people with 100 pages of regulation instead of 9,000 pages.
"You have some problems where you cannot even think about opening up new plants. You can't get approval for the plant and then you can't get approval to make the drug. Other than that you're doing fantastic," Trump said, which drew laughter from the meeting attendees.
Trump also called for pharma companies to bring their drug manufacturing operations back to the US during the meeting.
Trump also said he was concerned about FDA not approving drugs that could help a terminal patient.
"One thing that's always disturbed me is they come up with a new drug for a patient who's terminal and the FDA says we can't have this drug used on the patient," he said. "But they say the patient within four weeks will be dead. And [FDA says] well we still can't approve the drug. We don't know if the drug works or it doesn't work, but we can't approve the drug because we don't want to hurt the patient."
The comments seem to connect with those supporting efforts to expand state right-to-try laws. FDA also has been criticized for creating an administrative burden for a compassionate use application, although the agency has announced it streamlined the process. Sponsors are often hesitant to provide experimental products themselves, especially when everything that’s being produced is being used for clinical trials. (Also see "'Right To Try' Or 'Right To Ask'? Hearing Spotlights Adverse Events As Key Barrier To Expanded Access" - Pink Sheet, 26 Sep, 2016.)
Industry Appears To Like Trump's Ideas
Industry seemed to find Trump's comments positive.
Merck & Co. Inc. CEO Ken Frazier called the meeting a great conversation, saying it included talk about regulatory reform that also could stimulate innovation.
PhRMA CEO Steve Ubl also said in a statement that removing outdated regulations, along with tax reform and stronger trade agreements, could allow the pharma industry to create 350,000 jobs over 10 years.
The Biotechnology Innovation Organization also said it has advocated those ideas. "They will go a long way toward ensuring that patients have affordable access to today's innovative medicines and that our companies have the policy and regulatory environment they need to bring a new generation of breakthrough medicines to our children and grandchildren," BIO said in a statement.
Not surprisingly, Trump also told the industry representatives during the meeting that drug prices also need to come down, an issue he has raised repeatedly over the past several weeks.
Would Pharma Prefer A Lax FDA?
Trump’s remarks blaming FDA for a lack of new drugs are standard Republican talking points, but they come at a time when the agency’s review performance is quite strong by historical standards.
FDA review tends to be among the least time-consuming portions of the process. As of Dec. 9, 2016, the median time to approval for applications received in FY 2016 was 7.8 months overall, which is faster than the 12-month review goal for standard NME reviews and 8-month goal for priority NME reviews. However, FDA also saw its approval count decrease in 2016 compared to the previous year. (Also see "What Goes Up … US FDA Expects 2016 NME Approval Total To Come Down" - Pink Sheet, 8 Nov, 2016.)
Still, more early stage clarity and review-stage speed is always welcome. But two of Trump’s other initiatives could complicate FDA effort to provide it.
It not be possible to make FDA's review move faster than its current speed, especially in the wake of Trump's federal hiring freeze. (Also see "Next Steps On US FDA Hiring: Lobby For Strong Long-Term Plan After Freeze Is Lifted" - Pink Sheet, 25 Jan, 2017.) And development of regulations – and even guidances – will likely be slowed by the executive order that two regulations must be repealed for every one enacted. (Also see "Trump Order Reducing Regulation Might Imperil FDA Good Guidance Practices" - Pink Sheet, 30 Jan, 2017.)
FDA Commissioner Pick Coming Soon
Trump also may have implied that his search for an FDA commissioner has ended. He said "we have a fantastic person that I think I'll be naming fairly soon."
Four names have surfaced as potential commissioner candidates so far. (Also see "FDA Commissioner Candidate Gulfo Hates Breakthrough, Wants To Reevaluate User Fees" - Pink Sheet, 26 Jan, 2017.)
The timing of the pick likely will hinge in part on the confirmation of HHS Secretary nominee Tom Price, Republican representative from Georgia, who is awaiting a vote in the Senate Finance Committee before moving to the floor. (Also see "FDA's Next Commissioner: Will Trump Follow Hamburg Or McClellan 'Schedule'?" - Pink Sheet, 30 Jan, 2017.)
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Pink Sheet: 世界の薬事規制と承認審査に関するニュース
By Ian Schofield 31 Mar 2020
As part of its efforts to preserve patient access to medicines amid the COVID-19 pandemic, Russia is planning to cap...