In preparation for a vote this week, the House of Representatives Committee on Energy and Commerce yesterday released a new draft of the user fee reauthorization. The bill, titled the “FDA Reauthorization Act of 2017,” contains several new sections to align with user fee legislation passed by the Senate in May. There are about a dozen new provisions throughout the bill. The new titles and provisions of note include the following:
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A new Title V for pediatric drugs and devices. This title includes a section that would allow the FDA to require cancer drugs for adults that share a common target with a pediatric cancer to be studied in children starting in 2020 (Sec. 504).
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Expanded Title VIII, “Improving Generic Drug Access.” This title includes language establishing priority review for generics (Sec. 801) and regulatory transparency to increase competition (Sec. 802).
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A new provision that requires drug companies seeking orphan drug marketing exclusivity for a rare-disease drug demonstrate that the drug is clinically superior if it has the same active drug ingredient as an approved or licensed product (Sec. 607).
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A sense of congress that the Secretary of Health and Human Services “should commit” to working with Congress to lower the cost of prescription drugs via administrative or legislative actions (Sec. 609).
The House is expected to take up the legislation this week under a process known as suspension of the rules, which does not allow for amendments and requires a two-thirds vote for passage. It is expected that if the House clears the measure, the Senate will vote on the House bill later this month. The current user fee authorization expires on September 30th.
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