Deregulation could be the key to lowering high drug costs, said healthcare writer David Hogberg in an op-ed piece for the conservative publication The American Spectator.
Mr. Hogberg said it takes about eight to 12 years for a new drug to receive approval from the Food and Drug Administration. He believes transforming the FDA's regulatory process could help reduce the cost of medications.
Here are three FDA reforms Mr. Hogberg listed that could speed up the regulatory process.
1. Combine Phase I and Phase II of the approval process. Phase I clinical trials are used to test the safety of a drug and usually involve 20 to 80 patients. Phase II trials assess the drug's efficacy and involve 100 to 300 patients. Combining the first two phases of the approval process into one and testing the safety and efficacy of a drug at once could save millions of dollars and reduce the process by at least a year, said Mr. Hogberg.
2. Allow drugs approved in Europe to bypass FDA testing. Allowing a European Medicines Agency approval act as a substitute for an FDA approval would bring more drugs and drug uses to the market, thus making more competition to lower prices, according to Mr. Hogberg.
3. Update approval process for generics. While the FDA is supposed to use an abbreviated approval process for generic drugs, drugmakers must still go through the lengthy regulatory process if they wish to use a new delivery system for a generic drug. Mr. Hogberg believes the FDA should simply approve generic drugs and leave the decision of how to administer them to physicians and patients.
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