Dems blast Trump FDA pick as ‘dangerous’ choice

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. Ed Markey (D-Mass.) and Sherrod Brown (D-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.”

{mosads}Brown argued the 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 the FDA they will restrict how doctors can use a certain drug, but Gottlieb said neither the 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.”