Setting Sights On High Drug Prices, Gottlieb Steers FDA Into Waters Previous Chiefs Dared Not Tread

The Wall Street Journal: FDA Chief Proposes Rules Changes To Fight High Drug Prices
The new commissioner of the Food and Drug Administration plans a multifaceted effort to restrain high prescription-drug prices, centered on speeding cheaper generic medicines onto the U.S. market. Previous FDA commissioners have largely professed inability to act on drug costs, even as prices of drugs for cancer, hepatitis and other illnesses climbed to as much as hundreds of thousands of dollars per year or even therapeutic course. The FDA’s job, they said, is to assess safety and efficacy, and little else. (Burton, 5/25)

The Wall Street Journal: The Latest Drug Pricing Threat: The FDA
Health-care investors have another clear signal that regulatory scrutiny of high drug prices isn’t going away. Dr. Scott Gottlieb, the new commissioner of the Food and Drug Administration, made that clear Thursday morning, unveiling a host of policy plans that would enable the FDA to fight high drug prices in ways that the agency hasn’t done before. These policy changes are less drastic than say, overhauling rules surrounding how Medicare pays for prescription drugs, but they should generally be easier to implement. (Grant, 5/25)

Stat: Trump’s FDA Chief Punts On Defending His Boss’s Budget
Dr. Scott Gottlieb was in an awkward position. He’s been head of the Food and Drug Administration for just two weeks, and his boss, President Trump, is pushing a federal budget that would undo years of congressional work and risk bringing the agency to a grinding halt...Trump’s budget request, unveiled on Monday, calls for upending how the FDA has reviewed drugs and medical devices for 25 years. Under current law, companies pay user fees in exchange for product reviews, funding about two-thirds of the FDA’s budget for vetting drugs and devices. Now, in an effort to curtail federal spending, the White House wants to saddle the industry with the entire cost of product reviews, which would spell a roughly 70 percent increase in user fees. (Garde, 5/25)

CQ Roll Call: Lawmakers Skeptical Of Proposed FDA Budget Shift
House Appropriations subcommittee members at a hearing Thursday were skeptical of the Trump administration’s proposal to decrease the Food and Drug Administration’s taxpayer-funded budget by $1 billion in exchange for an increase of about the same amount in so-called user fees from regulated industries. The hearing marked the first appearance before Congress of new FDA Commissioner Scott Gottlieb since he was sworn in two weeks ago. Members pressed for his views on competition and pricing in the prescription drug market, the regulation of e-cigarettes, and food safety, which would lose funding under the Trump administration’s proposal. (Siddons, 5/25)

Politico Pro: FDA Hiring Freeze Lifted, Gottlieb Writes
The FDA is no longer subject to the hiring freeze the Trump administration imposed in late January, Commissioner Scott Gottlieb wrote this morning in an email to agency staff... He added more details will be forthcoming about a new streamlined and efficient process for filling job openings. The FDA currently has about 1,000 vacancies. (Karlin-Smith, 5/25)

In other pharmaceutical news —

Stat: Nevada Passes Bill To Limit Diabetes Drug Prices
In a setback for the pharmaceutical industry, the Nevada state assembly on Thursday voted in favor of a controversial bill aimed at lowering prices for diabetes medicines. The legislation, which passed the state senate last week, now goes to Governor Brian Sandoval. The bill is designed to lower costs by requiring drug makers to report pricing histories, disclose costs, and notify state officials and insurers in advance of price hikes above inflation. And a recently added amendment would also require drug companies to disclose rebates paid to pharmacy benefit managers, the middlemen that negotiate favorable insurance coverage. (Silverman, 5/25)