Life Science Compliance Update

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April 04, 2018

Is There a Decrease in FDA Regulations?

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According to an article in the Economist, FDA’s Commissioner Scott Gottlieb has overseen a fairly significant decrease in the amount of “economically significant” FDA regulations. The piece notes that some criticize the Commissioner for his industry ties. However, his tenure has pushed the agency to make it cheaper and easier for promising medications to reach patients.

Issuing Regulations

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According to the article, FDA regulations have dipped to a two-decade low. The agency has concentrated instead on two areas regarding the development of therapies and medicines. The first area is the adoption of new technologies by the FDA. This includes gene therapy and printed organs. “The FDA is keen to harness the potential of new technologies, whether that means using information from wearables in drug trials or enabling faster approval for new digital therapeutics.”

The second area of focus is on getting drunks to the market. The FDA has approved a record number of generic drugs in the past year. This, in turns, increases the amount of competition which is thought to bring the price down.

Furthermore, the FDA is also working to limit the amount of burdens on bringing a new drug to market. According to the article, the average cost of bringing a new medicine to market is at $2 Billion, up from $1.2 Billion in 2010.

FDA is also working to accelerate clinical trials. The agency is considering lowering the standard of efficacy but not safety. Instead of demonstrating that long-term outcomes are improved, a drugmaker might have to show only an improvement in a biological proxy for the disease. This approach is already in place for cancer drugs and its wider adoption could encourage innovation.

Regarding this trade-off, the Economist notes: “It may well be better to give people the option of a treatment in five years whose efficacy is known with 80% certainty than to wait 20 years for one with 99% certainty. But the shift increases the risk that money will be spent on new drugs that end up being no more effective than existing ones. This risk is particularly high in America, where the idea of paying for medicines on the basis of their actual performance is seen as an affront to patient choice. To get the benefit of faster innovation while [minimizing] the risk of unnecessary spending, that attitude has to change.”

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