News & Views: 5/17 - 5/23

May 24, 2022

The Senate HELP Committee released their draft user fee package.

In addition to reauthorization the FDA user fees, the package includes provisions to increase generic drug competition and expand the Cures Act. Notably, the package does not include any provisions pertaining to the accelerated approval pathway. While Ranking Member Burr (R-TX) believes that the FDA did not request any changes to the pathway, Chair Murray (D-WA) still plans to add accelerated approval pathway reforms to the package. To read the full press release, click here.

The House Energy & Commerce Committee unanimously passed their user fee package out of committee.

In addition to FDA user fee reauthorization, the package includes provisions that address the accelerated approval pathway, clinical trial diversity, generic drug competition, and the drug supply chain. The package combines key Democrat and Republican policies, including accelerated approval reform. To read more, click here.

Rep. Jan Schakowsky (D-IL) introduced legislation to adjust the biologic exclusivity period.

The PRICED Act would change the period of exclusivity granted to biologics from 12 years down to 5 years. The bipartisan bill intends to stimulate the biosimilar market by allowing for earlier entry of more affordable treatments. To read the full press release, click here.

Researchers at the University of Pennsylvania and Columbia Law School examined the timing of new formulations of novel drugs approved between 1995 and 2010 in a JAMA study.

The researchers found that 39.3% of the 206 drugs that they analyzed had new FDA-approved formulations after approval. Of the drugs that had additional formulations, they found that blockbuster drugs were 4 times more likely to have additional formulations and drugs that had been granted accelerated approval were 5.5 times more likely. New formulations were also found to be less likely after generic entry. To read the full study, click here.

Researchers at Harvard Medical School, US Court of Appeals, and the University of Calgary analyzed how inhaler manufacturers abuse patents and regulatory exclusivities in a Health Affairs study.

The researchers examined the sixty-two FDA-approved inhalers, fifty-three of which are brand name products. The average period of exclusivity on an inhaler is twenty-eight years, achieved by a combination of device hops and additional device patents. To read the full study, click here.

CIDSA Experts in the News

Richard Frank and Rachel Sachs were panelists on KFF’s Executive Actions to Address Prescription Drug Affordability in the US panel. Both Sachs and Frank acknowledged how the success of the COVID vaccine shows that the government and manufacturers can successfully make treatments accessible to the public. The panelists also discussed rebate proposals, international reference pricing, and march-in rights. To watch the panel, click here.

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