4:45 PM
 | 
Mar 31, 2017
 |  BioCentury  |  Politics, Policy & Law

Balancing act

Gottlieb’s priorities: implementing Cures Act, promoting generic competition

Scott Gottlieb’s toughest political challenge before and after confirmation as FDA commissioner will not be from a hostile Congress, but rather from White House officials who believe the agency is an impediment to medical progress and should get out of the way of patients who want to try unapproved drugs.

His first stop on the path to FDA’s White Oak campus will be the offices of members of the Senate Health, Education, Labor and Pensions (HELP) Committee, which must approve his nomination before it can be considered by the full Senate.

In these private meetings and at the confirmation hearing, HELP members will want to know Gottlieb’s plans for implementing provisions in the Cures Act they spent over a year debating and passing, as well as the pending PDUFA VI agreement. Congress has been told that Cures and PDUFA together will bring rapid, meaningful acceleration of drug development.

HELP’s senators also will press Gottlieb on his plans to use FDA’s powers to help reduce the cost of prescription drugs. Many will push him to endorse their efforts to get FDA to facilitate commercial importation of drugs from countries that impose price controls.

The epidemic of opioid addiction, abuse and overdoses also will be on the senators’ minds. Some will want to hear Gottlieb’s plans for helping to mitigate the crisis, while others will use the confirmation hearing to vent their anger and frustration at the agency for policies they believe have exacerbated the problem.

Given commitments President Trump and Vice President Pence have made to patient advocates to enact right-to-try legislation, Gottlieb will probably be pressed to describe how he will improve pre-approval access to medicines.

Throughout the confirmation process, Gottlieb will have one eye on the Senate and another on a White House that is looking for reassurance of its nominees’ loyalty and adherence to its ideology. He will have to position his policies in ways that are consistent with the White House’s emphasis on deregulation, reducing the federal workforce and economic nationalism.

“I always heard from industry that they want more guidance.”

Margaret Hamburg, former FDA commissioner

In addition to queries about policy, Gottlieb will face challenges from Democrats who will attack him personally over his financial ties to regulated industry and try to portray him as a lackey for big pharma (see “Gottlieb’s Disclosures”).

Last week, after meeting with Gottlieb, Sen. Patty Murray (D-Wash.) said in a statement, “President Trump promised to ‘drain the swamp,’ and as it stands, Mr. Gottlieb’s ties to the companies and industries he will regulate do exactly the opposite.”

These attacks are expected and will be largely rhetorical. Democrats privately express relief that Trump selected Gottlieb over several unqualified candidates who vowed to gut the agency’s approval standards. Endorsements from the two commissioners who served in the Obama administration, as well as from academics who are leading pharma critics, should help garner enough votes from Democrats to secure confirmation (see “Support of Commissioners Past”).

Once he’s confirmed, Gottlieb will probably spend more time dodging friendly fire from the White House than deflecting attacks from congressional Democrats. The...

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