Viewed As ‘Prison Guard’ To Innovation By Trump’s Advisers, FDA Could Have Target On Its Back
Meanwhile, the agency is punting a decision to Congress and the incoming administration over how to regulate certain medical tests.
Could The FDA Be Dismantled Under President Trump?
Has President-elect Donald Trump put a bull’s-eye on the Food and Drug Administration? It’s been less than a year since Robert Califf was sworn in as the Food and Drug Administration’s chief, but already the agency is facing post-election upheaval. Public health advocates are bracing for a seismic shift: a surrender of the agency’s rules for off-label promotion of drugs; the importation of more drugs from other countries; and fewer requirements for clinical trials — long the gold standard for determining whether medicines are safe and effective. (Kaplan, 11/22)
FDA Puts Off Closing Lab-Test 'Loophole,' Leaving Decision To Congress And Trump
After arguing for months that certain medical tests led to patients being mistakenly told they had illnesses and undergoing pointless treatment, the Obama administration Friday dropped its plans to regulate them. The Food and Drug Administration said a decision on whether and how to regulate the tests would be left to Congress and the new president. The diagnostics, known as laboratory developed tests, are designed, manufactured, and used within a single laboratory, often in a hospital. They range from simple tests that measure levels of sodium to ones that analyze DNA and help diagnose genetic diseases. (Kaplan, 11/18)
In other news concerning public health under the new administration —
The Washington Post:
The Challenges To Public Health Under The Trump Administration
Some of the greatest challenges facing the United States aren’t terrorists or trade deficits, but public health threats. Experts are urging the next administration to support the Centers for Disease Control and Prevention and its international collaborations to protect people from preventable deaths. (Sun, 11/21)
Biden’s ‘Moonshot' Against Cancer Hangs In The Balance
Vice President Joe Biden’s cancer “moonshot” is in serious jeopardy following Donald Trump’s election, but there may be hope for it yet. The president-elect hasn’t said anything about the initiative, launched by the Obama administration earlier this year, and his aides didn’t reply to multiple requests for comment. But the lame-duck Congress is making a last-ditch effort to pass a medical innovation bill that would provide hundreds of millions of dollars in funding for the effort. And if that money is approved before Trump is inaugurated, there might not be anything the new president could do, even if he wanted to stop it. (Scott, 11/22)
The Wall Street Journal:
Some In Marijuana Industry Fear Jeff Sessions Will Hinder — Or Reverse — Legalization Trend
Seven states passed ballot initiatives easing marijuana laws this year, four of them legalizing it for recreational use. But some in the nascent, if growing marijuana industry fear President-elect Donald Trump’s nomination of Sen. Jeff Sessions for attorney general will hinder progress toward legalization. (Kite, 11/21)
And Stat offers a look at the billionaire doctor hanging out with Trump —
Who’s The Billionaire Doctor Palling Around With Donald Trump?
Dr. Patrick Soon-Shiong, a biotech billionaire with a penchant for bluster, dined with Trump at a New Jersey country club over the weekend to discuss the future of medicine. It’s unclear how he might serve a Trump administration — but one possibility would be taking over the cancer moonshot initiative launched by Vice President Joe Biden. Soon-Shiong advised Biden on that program last fall — and then promptly launched his own Cancer MoonShot 2020, which brings together several biopharma companies to develop new immunotherapy treatments for cancer. (The initiative also happens to advance several of Soon-Shiong’s business interests, as it uses his genetic testing technology to find patients to participate in clinical trials of his companies’ drugs.) (Garde, 11/21)