How a reformed FDA can speed up delivery of lifesaving drugs
The Biden administration favors a proposal to waive patent protections for the COVID-19 vaccines. But there are other ways to remove impediments to pharmaceuticals that would accelerate development of lifesaving drugs and improve access. Bold reforms of intellectual-property law and the Food and Drug Administration (FDA) are required.
For example, the mandate of the FDA should be changed to require it to evaluate and certify only the safety of a proposed new drug, not its efficacy. Such a change would keep dangerous drugs off the market but allow safe drugs to be distributed sooner. That way, people who could benefit from new drugs could obtain them faster, cutting the time in which manufacturers were left uncompensated for their efforts. This reform would reduce the high cost of drug development.
If the FDA’s mandate was scaled back to safety, not efficacy, and uncompensated costs fell, a case could be made for shortening the duration of pharmaceutical patents. Patent holders are typically granted protection for up to 20 years from the date of filing. Shortening the patent term would also reduce the incentive for so-called “patent trolls” to file frivolous patent applications and lawsuits with no intention to use the patent productively, a costly obstacle to innovation.
Such a reform would have the benefit of reducing the total number of patents that other innovators must navigate to ensure they did not infringe on an existing right holder. Today, complex arrays of property rights, or “patent thickets,” can reduce the application of new ideas and make it more difficult to commercialize new products, especially pharmaceuticals.
Even more could be done to speed up the process. With transparent disclosures, drugs approved in select foreign countries should be allowed on the U.S. market. International reciprocity would permit drugs to reach consumers quicker in the United States, bypassing FDA regulatory bottlenecks, which according to a recent estimate help drive up the average cost of bringing a new drug to market to $2.8 billion.
Both the Pfizer/BioNTech vaccine and the Oxford/AstraZeneca vaccine were authorized for use in the United Kingdom before the United States. The Oxford/AstraZeneca vaccine is still awaiting approval. If reciprocity had existed, millions of Americans could have been immunized sooner, potentially saving hundreds or thousands of lives. This is not only true for vaccines. Reciprocity across all drugs could save millions of lives.
Further, a “prize model” to incentivize and compensate drug innovators should be adopted widely in the United States and around the world. Under this approach, governments, private nonprofits, and others would offer lump-sum grants — $5 billion, say — to any company or partnership that developed a drug that cured an identified disease such as the common cold, HIV-AIDS, or a type of cancer.
As a condition of receiving the lucrative prize, the winner would be required not to patent the new knowledge. Such a stipulation would allow the world’s scientific community immediately to learn from and build on the new knowledge.
A variation of the prize model was used, in effect, during development of Pfizer’s COVID-19 vaccine, since the company rejected U.S. government money up front, but accepted a $2 billion advanced purchase agreement (the “prize”). This approach reduces government interference in R&D, freeing entrepreneurs to innovate while being adequately compensated.
It is past time to redefine the FDA’s mission, shorten the duration of pharmaceutical patents, reduce the burdens of patent thickets and patent trolls, allow international reciprocity in new drug approvals and offer more prizes in place of patents. These bold reforms would improve access to potentially lifesaving drugs, increase drug breakthroughs, and accelerate the use of new scientific knowledge for generations to come.
Lawrence J. McQuillan is a senior fellow and director of the Center on Entrepreneurial Innovation at the Independent Institute in Oakland, Calif. He is a coauthor of COVID in California: How Government Regulations Created Critical Healthcare Shortages.