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Regulatory Focus™ > News Articles > 2019 > 6 > Senate Committee Advances Health Cost Bill With Changes Impacting FDA

Senate Committee Advances Health Cost Bill With Changes Impacting FDA

Posted 26 June 2019 | By Zachary Brennan 

Senate Committee Advances Health Cost Bill With Changes Impacting FDA

The Senate Committee on Health, Education, Labor & Pensions (HELP) on Wednesday voted 20-3 to advance a bill aimed at lowering health care costs that includes 54 proposals from a bipartisan group of 65 senators, including more than a dozen that impact the US Food and Drug Administration (FDA).

The sections on reducing the price of prescription drugs include various changes to the way FDA operates, including alterations to the citizen petition process, modernizing the Orange and Purple books, new provisions to trigger 180-day exclusivity for first generics and new authorities for FDA to address outdated generic drug labels.

In addition to those provisions, the Senate HELP committee also added a measure from Sen. Tammy Baldwin (D-WI) by a vote of 17 to 6 that would require drug manufacturers to notify the Department of Health and Human Services and submit a transparency and justification report 30 days before they increase the price of certain drugs that cost at least $100 by more than 10% in one year or 25% over three years.

The Senate bill also includes the CREATES Act, passed by the House in May, which aims to increase generic drug competition by thwarting pay-for-delay deals.

Despite the bipartisan nature of the bill and no opposition from industry group PhRMA, the only contentious provision in the bill is related to the tweaks to a first generic’s 180-day exclusivity. Two amendments that would have removed those changes in the bill were both pulled on Wednesday.

Former FDA Commissioner Scott Gottlieb defended the 180-day exclusivity changes, saying: “We need to make sure while we take steps to end the opportunity for some generic firms to sit on their 180-day ticket and block other filers from entering market, we must protect generic firms that are acting in good faith to gain market entry.”

But the generic industry group Association for Accessible Medicines (AAM) opposed the changes and said that if the 180-day clock “starts when a first applicant is waiting on the FDA or is prevented from launching due to patents, significant uncertainty is introduced around whether the 180-day incentive will be available to future applicants.”

Sens. Elizabeth Warren (D-MA), Bernie Sanders (D-VT) and Rand Paul (R-KY) voted against the bill. Warren said she voted against it partly because it does not hold drugmakers accountable for soaring prices.

Senate HELP Committee


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