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

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