Author:
Preston Brashers, Research Fellow
Affordability 101 · Chapter 5: Freedom to Innovate and Compete
Plymouth Institute for Free Enterprise
Topline
Policymakers should fast-track approval of lifesaving drugs and medical devices that have been approved by trusted regulatory bodies of selected nations.
Background
Development of new drugs is a hit-or-miss process. Only about 8% of Phase I drugs make it through all three drug trial phases and the regulatory stage to finally receive approval from the Food and Drug Administration (FDA). On average, it takes about 10.5 years for successful drugs to move from Phase I trials to FDA approval. Regulators tend to err on the side of moving too cautiously, because they can face stark consequences for approving drugs that turn out to be unsafe or ineffective, but they face minimal consequences for delaying approval of potentially lifesaving drugs. Surmounting these regulatory hurdles can be prohibitive, especially for drugs meant to treat rare conditions for which there is a small potential market.
Multiple International Markets, Multiple Regulatory Bodies
- International regulators like the European Medicines Agency (EMA) and Health Canada (HC) tend to be cautious but sometimes approve drugs before the FDA.
- A 2017 BMJ Open study identified drugs that EMA or HC approved in the early 2000s for which FDA approval was lagging or non-existent.
- Revisiting the status of 23 potentially lifesaving drugs in the BMJ study shows that 15 now have FDA approval, 5 are still marketed abroad, 2 were withdrawn for commercial reasons, and only 1 was later withdrawn for safety or efficacy reasons.
Action Items (Congress and FDA)
- Congress should enact legislation that allows an expedited approval process for drugs and medical devices if the sponsor demonstrates that:
- The drug or device has received approval from the relevant regulatory body of one or more designated allied nations as a treatment for a condition that is often life-threatening; and
- No such regulatory authorities have actively denied, suspended, or withdrawn approval of the drug over safety or effectiveness concerns;
- If the FDA doesn’t issue a written determination declining approval of the drug or device within 30 days, it should be deemed approved or conditionally approved for use by patients with life-threatening conditions.
How It Would Make Life More Affordable
- It would reduce duplicative red tape in the drug approval process.
- It would reduce the time and cost of getting lifesaving drugs and medical devices to the market, encouraging more innovation and creating more competition.
Related Legislation: RESULT Act (S. 3081, H.R. 1632).
Bottomline
Delaying drugs that regulators have approved costs money and lives.
This memo is part of Affordability 101, Advancing American Freedom’s playbook of 101 policy solutions to make life more affordable.
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