When it comes to cozy business relationships between government and industry, there is nothing like the lucrative one that Congress has encouraged federal health agencies to create with the drug and vaccine industry. One hand washes the other.

Have you ever wondered how some new drugs and vaccines vault to the front of the line of the FDA’s licensing process using fast-track approvals? One way is through a federal law, the Food and Drug Administration Amendments Act passed by Congress in 2007, which allows a company developing a treatment for a neglected or rare pediatric disease to pay the FDA for a priority review voucher (PRV).

Although FDA approval is not guaranteed, most of the time a PRV secures fast-track approval in six rather than 10 months.^1,2 According to the FDA, to earn a priority review designation, a pharmaceutical product must pose “significant improvements in the safety or effectiveness of the treatment, diagnosis or prevention of serious conditions when compared to standard applications.”

The company seeking approval must also provide “evidence of safety and effectiveness in a new subpopulation.”³ The PRV was created and included in the 2007 law to provide an incentive to companies developing nonprofitable drugs for rare pediatric diseases, but has proved to be a windfall for companies producing vaccines.

Selling PRVs to Get Jump on Securing Market Share

Under the law, drug companies developing treatments for neglected and rare pediatric diseases may sell the PRVs they have purchased from the FDA to other companies, including vaccine manufacturers, for millions of dollars to fast-track the licensure of completely different, profitable drugs and vaccines.

When sold, the PRVs designed to help small companies fund their development of nonprofitable disease treatments can give extreme advantages to multinational corporations developing and selling other high-priced drugs and vaccines.

“If you develop a new drug for malaria, your profitable cholesterol-lowering drug could go on the market a year earlier,” said Bill Gates at the World Economic Forum in Davos in 2008.

Describing the 2007 law creating PRVs, Gates pointed out that, “This priority review could be worth hundreds of millions of dollars.”⁴ The Bill and Melinda Gates Foundation has invested hundreds of millions of dollars in the vaccine industry.⁵

Early PRV approval from the FDA gives drug companies several months of additional sales because the first licensed drug or vaccine in a category to reach the market often becomes the front-runner, leaving competitors in the dust.

For example, Regeneron and Sanofi bought a PRV in the hopes that its cholesterol drug Praluent would beat Amgen’s Repatha to market.⁶ Gilead paid $125 million for a PRV and AbbVie paid $350 million, in addition to the $2.7 million paid to the FDA for the shortened review.⁷

As Gates pointed out, companies that purchase PRVs stand to make millions on pharmaceutical products that the FDA fast-tracks to market. PRVs, then, appear to be primarily making money for drug companies rather than truly helping patients suffering with rare and neglected diseases.

Congress Gives Pharma Edge Over FDA Regulators

The FDA is charged with the legal duty to regulate the food and pharmaceutical industries to ensure that prescription drugs, vaccines and other biological products, medical devices and certain types of foods are safe, labeled properly and effective before being released for use by the public.⁸

Reportedly, FDA officials objected to the priority review program, which was included in the 2007 law passed by Congress without soliciting input from FDA staff.⁹ According to an unnamed FDA source, “FDA does not get a true seat at the table” during the legislative process so “well-meaning academics, advocates and legislators ‘sold’ FDA to the highest bidder in setting up this program.”¹⁰

Critics of the PRV program point out that it does not really encourage drug development for rare diseases. Since medical reviewers in FDA cannot be easily moved from one review division to another in order to handle PRVs, it creates added workload strain to an overtaxed regulatory agency that is understaffed.

The program also makes it easier for pharmaceutical products, for which there are existing treatments, such as for diabetes or cholesterol, to move to the front of the approval line at the expense of other, more important ones for which there are no treatments.

For example, Janssen used a PRV to accelerate the approval of Tremfya (guselkumab) to treat plaque psoriasis, a lucrative drug category competing with the best-selling psoriasis drug, Humira.¹¹ Drug giants Gilead Sciences and Jazz Therapeutics have also bought PRVs.