Will FDA’s New Review Process Sell Drug Approvals to the Highest Bidder?
/By Crystal Lindell
The U.S. Food and Drug Administration has launched a new speedy review process for new medications, dubbed the Commissioner’s National Priority Voucher (CNPV) program.
The FDA claims the program will speed up the approval process for pharmaceutical companies looking to get new drugs on the market – but it remains unclear whether it will be based on need and effectiveness, or just how much companies are willing to pay.
Specifically, the FDA said the CNPV program will shorten the review time to 1-2 months, compared to the typical 10-12 months it usually takes after a company’s final drug application.
They’ll accomplish this by allowing for “a team-based review.” This differs from the current process, where a drug application is “sent to numerous FDA offices” to give them a chance to weigh-in.
The program will even allow companies to submit the lion’s share of the drug application before a clinical trial is complete, according to FDA Commissioner Marty Makary, MD.
“Using a common-sense approach, the national priority review program will allow companies to submit the lion’s share of the drug application before a clinical trial is complete so that we can reduce inefficiencies. The ultimate goal is to bring more cures and meaningful treatments to the American public,” Makary said.
Neither the FDA press release about the new program or its "Frequently Asked Questions" page specify how much this new program will cost companies interested in participating.
We can gain some frame of reference by looking at what the existing Priority Review and Priority Review Voucher costs for companies, as well as what their true value is.
While the FDA charges companies about $2.5 million for those vouchers, according to the General Accounting Office (GAO) they have been resold on the secondary market for as much as $350 million. The GAO found that of the 31 vouchers awarded by the FDA between 2009 and 2019, over half (17) were sold to another drug company.
The new vouchers are not able to be transferred to other companies as of now, but with so much money at stake, you have to wonder if there will be a valuable aftermarket for them.
Even if the new vouchers themselves are reasonably priced, my guess is that they will be more likely to go to companies that donate money to elected officials or are politically favored.
The FDA says that in the first year of the program it will give a limited number of vouchers to companies “aligned with U.S. national priorities,” which include “unmet public health needs” and increased domestic drug manufacturing. But then they also say the vouchers “can be applied to drugs in any area of medicine.”
In other words, basically any medication would qualify. There’s not much else to explain just how vague the criteria is for receiving the vouchers.
And if any medication would qualify for the new vouchers, it makes sense that the ultimate qualification would be what companies are willing to pay to get them.
Under the current voucher system, the GAO found there is “no obligation to make the approved drug available at an affordable price,” so companies are free to limit access and charge whatever they want. The new voucher system also has no requirement that new drugs will be affordable or accessible.
While I do understand the need for more efficiencies in the drug review process, when those efficiencies are applied unevenly, it inevitably invites corruption. And the last thing we need when it comes to prescription medications and healthcare in our country is more corruption.
My concern is that the drugs getting speedy review won’t actually be the ones that are in the public’s best interests, but rather the ones that best serve the interests of our elected officials and the drug companies themselves.
And when it comes to prescription medications, we all know that what’s best for politicians and the pharmaceutical industry is not what’s best for patients.
