Overnight Regulation: Dems say Trump FDA nominee too close to drug industry

Overnight Regulation: Dems say Trump FDA nominee too close to drug industry
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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 where GOP lawmakers appear to be making a second go at efforts to repeal and replace ObamaCare. 

Here's what else is going on. 


Senate Democrats are sounding the alarm on President Trump's nominee to head the Food and Drug Administration (FDA), calling the pick a "dangerous" choice.

In a call with reporters Tuesday, Sens. Edward MarkeyEdward (Ed) John MarkeyDemocrats urge Rick Perry not to roll back lightbulb efficiency rules Ocasio-Cortez taps supporters for donations as former primary opponent pitches for Kennedy Rep. Joe Kennedy has history on his side in Senate bid MORE (Mass.) and Sherrod BrownSherrod Campbell BrownBlood cancer patients deserve equal access to the cure Trump admin abruptly delays funding for human trafficking victims: report Overnight Energy: Lawmakers show irritation over withheld Interior documents | Republican offers bipartisan carbon tax bill | Scientists booted from EPA panel form new group MORE (Ohio) said nominee Scott Gottlieb is too closely connected to the pharmaceutical industry to fight the opioid epidemic.

"We are suffering this public health epidemic because big pharma pushed pills they knew were dangerous and addictive, the FDA approved them, often without expert counsel, and doctors – because they do not have mandatory education on these drugs – prescribed them," Markey said.


"It is a vicious and deadly cycle that has turned this nation into the United States of Oxy. And it must stop."

Brown argued FDA needs a leader to step up agency efforts to fight addiction, not someone who will "roll over for his big pharma friends."

The press call comes ahead of Gottlieb's nomination hearing Wednesday, when he will face questions from members of the Senate Health, Education, Labor and Pensions Committee.

Gottlieb, a former deputy FDA commissioner during the George W. Bush administration, has reportedly served as a consultant to some of the world's biggest pharmaceutical companies, including GlaxoSmithKline and Bristol-Myers Squibb.

In an ethics agreement late last month, Gottlieb promised to recuse himself for a year from agency matters that directly impact more than two dozen different companies and divest his financial interests.

But Markey and Brown raised specific concerns Tuesday over Gottlieb's public opposition in 2013 to the FDA's Risk Evaluation and Mitigation Strategies -- manufacturer agreements required for agency approval of certain risky drugs.

In an op-ed for Forbes at the time, he called them "regulatory burdens."

In the agreements, manufacturers often promise FDA to restrict how doctors can use a certain drug, but Gottlieb said neither FDA nor manufacturers actually have the needed authority over doctors to do so. 

Markey however, called the agreements "vital tools" that should be strengthened not eliminated.

The senators also pointed to a 2012 op-ed Gottlieb wrote in Forbes calling into question the Drug Enforcement Administration's (DEA) authority to police opioids.

By going after pharmacies and drug distributors, Gottlieb said the DEA was burdening innocent patients.  

He said DEA police should deal with illegal narcotics on the street and let industry experts at the Department of Health and Human Services "find the providers and suppliers who are breaking the law."

Markey called Gottlieb's arguments flawed. 

"Take away DEA oversight over prescription opioids and give that authority to the FDA. Then, at the same time, limit the FDA's ability to utilize its full oversight authority over these addictive products," Markey said. 

"That would leave a mostly unregulated marketplace for big pharmaceutical companies and their opioid painkillers to thrive, while American families pay the highest price with their lives."

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The Senate Health, Education, Labor and Pensions committee will hold a confirmation hearing on the nomination of Scott Gottlieb to lead the Food and Drug Administration. 

The House Education and the Workforce Subcommittee on Workforce Protections will hold a hearing to discuss the Working Families Flexibility Act, a bill to allow private-sector workers to receive paid time off or comp time for overtime hours worked.

The House Small Business Committee will hold a hearing on working with small businesses to improve the Small Business Administration. SBA Administrator Linda McMahon is expected to testify. 

The House Appropriations Subcommittee on Labor, Health and Human Services, Education and Related Agencies will hold a hearing to look at the federal response to the opioid abuse crisis. 


Keep an eye on these rules in Wednesday's edition of the Federal Register.

--The Fish and Wildlife Service (FWS) will loosen the protections for certain manatees.

The West Indian manatee was listed as an endangered species in 1967, but the agency will downgrade the species' status to threatened.

The critical habitat for these manatees will stay in place.

The changes go into effect in 30 days.

--The FWS will weaken the protections for certain parrots.

The turquoise parakeet and scarlet-chested parakeet were both listed as endangered species in 1970, but the agency says the parrots no longer warrant these protections.

They will both be removed from the Endangered Species List.

The changes go into effect in 30 days.

--The FWS will propose new protections for freshwater mussels.

The FWS will propose listing the yellow lance mussel as a threatened species. The protections stem from a petition by the Center for Biological Diversity.

The public has 60 days to comment.



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3: Proposed rules

6: Final rules

(Source: Wednesday's Federal Register)



"I have to show this chart to you, because it's amazing, actually," President Trump said in a speech to the National Association of Building and Construction Trades in Washington, D.C. on Tuesday.

Trump used a giant chart to show all the regulations that must be complied with to build a highway, regulations he said were getting in the way of his potential $1 trillion infrastructure plan.

We'll work to stay on top of these and other stories throughout the week, so check The Hill's Regulation page (http://thehill.com/regulation) early and often for the latest. And send any comments, complaints or regulatory news tips our way, tdevaney@thehill.com or lwheeler@thehill.com. And follow us at @timdevaney and @wheelerlydia.

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