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Regulatory Focus™ > News Articles > 2019 > 5 > Senate Bill to Cut Health Costs, Targets FDA Tweaks

Senate Bill to Cut Health Costs, Targets FDA Tweaks

Posted 23 May 2019 | By Zachary Brennan 

Senate Bill to Cut Health Costs, Targets FDA Tweaks

The Senate Health, Education, Labor and Pensions (HELP) committee on Thursday unveiled a discussion draft of a new wide-ranging bill to help cut health care costs.

The draft includes nine sections related to the US Food and Drug Administration (FDA), including efforts mirroring House-passed bills reforming the Orange Book and Purple Book, as well as initiatives to increase generic drug competition.

Former FDA Commissioner Scott Gottlieb praised the Senate draft: “These measures WILL lower prices. The most tangible set of bipartisan reforms to emerge.”

Among the pro-competitive provisions, the draft seeks to prevent first-to-file generic drug applicants from blocking, beyond the 180-day exclusivity period granted by FDA, the entrance of subsequent generics. Another provision would also trigger the start of the first-to-file generic drug applicant’s 180-day exclusivity when a subsequent applicant has been tentatively approved and the first-to-file applicant has not received final approval within 30 months of submitting its application.

The bill also tightens the definition for eligibility for five-year new chemical entity (NCE) exclusivity to prevent evergreening, clarifying that the exclusivity is available only for a drug containing no active moiety that has been previously approved in the US.

Several other provisions would also help biosimilar manufacturers.

For instance, the bill would prevent delays related to compliance with USP standards by excluding all biologics subject to regulation under the Public Health Service Act from requirements to follow USP compendial standards.

The bill also addresses the transition next March for certain biologics approved under new drug applications, clarifying that such products, including insulin products, cannot receive new, extended market exclusivities.

At the same time, the bill preserves certain unexpired exclusivities for biologics undergoing the transition and ensures that marketing applications submitted six months prior to the transition that are still under FDA review at the time of the transition date will not have to be resubmitted.

The bill also goes after pharmacy benefit managers (PBMs), preventing them from engaging in spread pricing, or charging a plan sponsor, health insurance plan or patient more for a drug than the PBM paid to acquire the drug. Another provision would require PBMs to pass on 100% of any rebates or discounts to the plan sponsor.

Separately, the House Ways & Means Committee floated a draft bill on Thursday to establish an out-of-pocket cap for Medicare beneficiaries.

Discussion Draft

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