What’s the news: Congress is taking on skyrocketing prescription-drug prices. Six bills aimed at speeding generic drugs to market, boosting price transparency and ending anti-competitive gaming of the patent system were approved by the House Energy and Commerce Committee with bipartisan support.
Why it matters to patients and physicians: Almost 10% of personal health spending—$333.4 billion in 2017—went toward prescription drugs and high pharmaceutical prices pose a substantial barrier to medication adherence with major effects on patient outcomes.
Five of these bills were approved by voice vote and the sixth passed 51–0, illustrating the strong bipartisan support this effort has.
The bills “represent important and critically needed steps forward to increase competition and transparency,” AMA Executive Vice President and CEO James L. Madara wrote in a letter to leaders of the panel’s subcommittee on health.
“The AMA applauds your leadership and efforts to advance legislation that will address anti-competitive behaviors and misuse of current laws, regulations and policies that were established by Congress and regulators to spur innovation while safeguarding safety and efficacy,” Dr. Madara added.
The issue of drug-price transparency has been a focus of AMA advocacy efforts such as the TruthinRx campaign.
The package of legislation contains two provisions the AMA has long advocated for.
One is to prohibit “pay-for-delay” settlements in which a manufacturer pays a potential generic competitor to drop its patent challenge. The other is to end the practice of indefinitely “parking” a generic drug in the 180-day exclusivity period by delaying final Food and Drug Administration approval of an application as part of a settlement agreement with a brand-name drug manufacturer.
The AMA also favors:
- Shortening the exclusivity period for biological products.
- Requiring drugmakers to provide public notice before raising prices by 10% or more each year and to provide justification.
- Requiring disclosure of costs for clinical trials, production, marketing and advertising.
What’s next: The bills could be considered by the entire House before members leave April 12 for a two-week recess, though it is more likely they will do so later this spring, after they return. A second hearing specifically on the cost of insulin is scheduled for April 10.