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Regulatory News | 18 March 2016 | By Zachary Brennan
Almost a decade into the experiment of offering lucrative priority review vouchers (PRVs) to help speed the development of treatments for neglected tropical and pediatric diseases and it seems Congress’s love of the vouchers has only just begun.
And although that love is sure to be a good sign for companies looking to make hefty profits off of the vouchers on the open market (selling for upwards of $350 million), it’s a bad sign for the US Food and Drug Administration (FDA), which has already explained its opposition to the programs as they require expedited reviews of drugs that might not be public health priorities.
On Thursday, the Senate officially signed off on adding the Zika virus to the tropical disease priority review voucher (PRV) program, which, if the identical bill in the House passes, would make it the 22nd tropical disease eligible for the program. Other diseases on the list currently include Chagas, Tuberculosis and Malaria.
But the program has come under fire, with Doctors Without Borders raising concerns of companies winning these vouchers, which allow sponsors to speed the review of any one of its new drug products from the standard 10-month review period to a six-month expedited review or to sell them on the market, for research they didn’t conduct.
Martin Shkreli’s former company Kalobios is seeking a PRV and FDA approval for benznidazole, a Chagas disease treatment the company acquired for $2 million upfront in December 2015. If the drug wins approval, the company could potentially sell the PRV acquired because of the approval for hundreds of millions of dollars.
Back in September, Harvard Professor Aaron Kesselheim also 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.
The Senate’s passage of a bill adding Zika to the list of qualifying tropical diseases (which FDA could’ve already added with an order) comes as the Senate Health, Education, Labor & Pensions committee earlier this month also advanced a bill that would reauthorize the rare pediatric PRV program through 2022.
In addition to those two current programs, the Senate and House are also considering a PRV program for medical countermeasures, which advanced this week in the Senate, as well as a neonatal PRV program, and another PRV program for some generic drugs is in the works.
On Thursday, Rep. Kurt Schrader (D-OR) introduced a companion bill to a Senate bill to create the generic PRV program that would seek to incentivize the development of generics that are currently on FDA’s drug shortage list or that lack a sufficient number of competitors. The new program would require FDA to act on an abbreviated new drug application (ANDA) in 150 calendar days (rather than the six months priority review for new drugs) and the vouchers can only be used to speed the review of other ANDAs.
But the appetite for creating a generic PRV program in Congress comes as FDA just a week ago amended which ANDAs it would expedite, including applications for “sole-source” generics, meaning ones with limited competition. FDA also already prioritizes ANDAs for drugs on its shortage list, though FDA's definition of a priority review is not defined and is potentially longer than 150 calendar days.
Tags: generic competition, priority review voucher, PRV program, Zika PRV, generic PRV