Overnight Regulation: Senate confirms Trump’s pick for FDA

Welcome to Overnight Regulation, your daily rundown of news from the federal agencies, Capitol Hill, the courts and beyond. It’s Tuesday evening here in Washington.

 

THE BIG STORY

The Senate on Tuesday confirmed Scott Gottlieb, President Trump’s nominee to lead the Food and Drug Administration (FDA).

Gottlieb, a former FDA director and deputy commissioner under former President George W. Bush, was confirmed in a 57-42 vote. He will replace Robert Califf, the acting FDA chief who was appointed last year by former President Barack Obama.

“As a practicing physician with a wealth of policy experience, Dr. Gottlieb has the necessary qualifications to lead the FDA at this critical time,” Senate Majority Leader Mitch McConnell (R-Ky.) said Tuesday on the Senate floor.

{mosads}”Not only has he worked in hospitals, interacted directly with those affected by disease and treatment, but he also has developed and analyzed medical policies in both the public and private sectors,” McConnell added.

Democrats had raised concerns about Gottlieb’s financial ties to the industries he will be charged with regulating.

Gottlieb has invested in or consulted for dozens of healthcare companies since leaving the FDA.

But he committed to untangling those financial ties before taking over the agency. Gottlieb signed an ethics disclosure agreeing he would recuse himself for one year from any decisions about 20 health companies he has worked with, including GlaxoSmithKline and Bristol-Myers Squibb.

Republicans, including Senate Health, Education, Labor and Pensions Committee Chairman Lamar Alexander (R-Tenn.), view Gottlieb’s work with industry as an asset.

During his confirmation hearing, Gottlieb vowed to make the opioid epidemic the FDA’s top priority, calling it “the biggest crisis facing the agency.” He also wants to make streamlining the approvals of generic drugs to bring costs down a priority.

The most vocal opponent of his confirmation was Sen. Edward Markey (D-Mass.), who said he fears that Gottlieb is too close to pharmaceutical companies that sell and promote opioids. In particular, Gottlieb was a paid expert witness for Cephalon when the company was sued for improperly marketing fentanyl, a powerful opioid that is now linked to hundreds of overdose deaths.

“We need FDA to be a tough cop on the beat, not a rubber stamp approving the latest big pharma painkillers,” Markey said during a floor speech Tuesday.

Moving forward, the new FDA chief will be tasked with taking a look at Obama regulations for electronic cigarettes and requirements for calorie counts on restaurant menus, as well as approvals for genetically engineered animals.

During the Obama administration, the FDA exerted its authority granted by Congress to regulate all tobacco products, including cigars and e-cigarettes, but it is unclear if Gottlieb will bend to industry pressure and roll back the regulations.

For the full story, click here.

 

ON TAP FOR WEDNESDAY 

The Senate Environment and Public Works Department will hold a hearing to look at state views on modernizing the Endangered Species Act. 

The Senate Judiciary Committee will hold a hearing to consider Steven Andrew Engel and Makan Delrahim to be assistant attorneys general, and Noel Francisco to be solicitor general of the United States. 

The Senate Small Business and Entrepreneurship Committee will hold a hearing on the nomination of Althea Coetzee to be deputy administrator of the Small Business Administration.

 

TOMORROW’S REGS TODAY

Keep an eye on these rules in Wednesday’s edition of the Federal Register:

–The National Marine Fisheries Service (NMFS) is moving to protect endangered shark species.

The National Marine Fisheries Service on Tuesday listed the daggernose shark, striped smoothhound shark, spiny angelshark and Argentine angelshark as endangered.

The narrownose smoothhound shark, meanwhile, is being listed as a threatened species.

The Obama administration proposed these protections in December 2015. They stem from a 2013 petition from WildEarth Guardians.

The protections go into effect in 30 days.

–The U.S. Department of Agriculture (USDA) will again delay Obama-era rules for livestock and poultry farmers.

The USDA’s Agricultural Marketing Service issued a series of livestock and poultry production requirements on the last full day of the Obama administration. They included handling and transportation requirements for livestock, as well as living condition standards for poultry.

This is the second time the Trump administration will delay the rules, which are now scheduled to go into effect on Nov. 14.

–The Federal Communications Commission (FCC) will propose pulling back some “regulatory impediments” facing wireless companies.

The FCC’s goal is to promote investment and deployment of the infrastructure for wireless networks around the country by reducing regulatory burdens on these companies.

The public has 30 days to comment.

 

NEWS RIGHT NOW  

Humane Society: USDA records on puppy mills missing from website 

Schumer recommends consumer advocate for FTC 

Club for Growth calling on Trump to exit Paris climate deal

Trump delays decision on Paris climate pact

Why the FCC is unlikely to go after Stephen Colbert

Dems want details on FCC cyberattack after John Oliver critique

FCC flooded with net neutrality comments after John Oliver plea

US may expand laptop ban to European flights: report

EPA seeks governors’ input in rewriting Obama water rule

Dems request insider trading investigation into top Trump adviser 

One-third of new drugs had safety problems after FDA approval – NPR 

Why everything we know about salt may be wrong – The New York Times 

 

BY THE NUMBERS

11: Proposed rules

21: Final rules

(Source: Wednesday’s Federal Register)