Regulatory Focus™ > News Articles > House Looks to Reform Tropical Disease Priority Review Voucher Program

House Looks to Reform Tropical Disease Priority Review Voucher Program

Posted 08 June 2016 | By Zachary Brennan 

House Looks to Reform Tropical Disease Priority Review Voucher Program

The House Energy and Commerce Committee on Wednesday passed by voice vote an amendment (to an unrelated bill on hospital preparedness for dangerous threats) that would significantly change the priority review voucher (PRV) program for tropical diseases.

Background

Since 2009, the US Food and Drug Administration (FDA) has issued nine PRVs to reward companies for developing new drugs to treat rare pediatric and tropical diseases with a voucher that can be sold on the open market, and have earned companies as much as $350 million, as they can expedite a drug’s review by FDA by four months.

Despite the recent expansion of the tropical disease PRV program to include the Zika virus (making it the 22nd tropical disease eligible for the program), many critics of the program have emerged to complain that companies are being rewarded for treatments they did not develop.

Harvard Professor Aaron Kesselheim raised questions about the program, particularly as the first tropical disease PRV was granted in 2009 to Novartis for the antimalarial artemether-lumefantrine, though at the time of FDA approval, the drug was already approved in more than 80 other countries. Similarly, Knight Therapeutics received a PRV for miltefosine, a treatment for leishmaniasis, but Knight was not involved with the drug’s development.

FDA has also previously taken issue with the PRV programs, even going so far as to call to end them, though Congress has continued to press for new PRVs for different types of products, including generics and medical countermeasures.

New Amendment

Rep. G.K. Butterfield’s (D-NC) amendment to HR 3299 would, among other things, ensure that:

  • Tropical disease PRVs aren’t awarded to products that been previously approved in other countries;
  • More public information is made available on how sponsors plan to roll out their tropical disease drugs in other countries outside the US;
  • Sponsors provide more information on the estimated population worldwide suffering from the tropical disease, the estimated demand worldwide for the tropical disease product and the amount of the tropical disease product distributed worldwide;
  • FDA is notified of any PRV transfer so the agency understands what companies hold PRVs; and
  • GAO conducts a study to assess how the tropical disease PRV program is incentivizing new research and development in tropical disease products, the impact of implementing the program for the FDA, the number of products approved and awarded PRVs under the program, and how such products are meeting US government needs and global unmet needs, among other things.

“Under current law, there is no requirement that sponsors invest in new research to receive a priority review voucher,” a summary of the amendment says. “Of the three PRVs awarded under the tropical disease PRV program, two were to companies for drugs that were available for years outside the U.S.”

And unlike with the rare pediatric PRV program, the tropical disease PRV program does not include any reporting metrics regarding the tropical disease product following approval so the new requirement of the report will mirror the requirements of the rare pediatric PRV program.

AMENDMENT TO H.R. 3299


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