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Why Changes MUST Go Through Congress

4/6/2017 / by Dr. Evan Siegel  


The Food, Drug and Cosmetic Act and Public Health Services Act; Must be Changed through new Law in Congress

Last week, we identified a number of areas that would be impacted if there were major changes in how the FDA approved marketing applications.

The first area of impact is the 1962 amendments to the Food, Drug, and Cosmetic Act and the Public Health Service Act. Laws and regulations would need to be changed to result in functional differences in how drugs are evaluated by FDA (an Executive Order can’t do it!)

Congressional approval of one or more laws that would modify or void these Acts is necessary prior to any move to change the FDA review and approval process as well as industry strategies, expenditures and timeframes for moving new products to market.

Some changes could radically alter the risk/benefit profile of drugs and biologicals in the US, with fallout around the world. Nonclinical pharmacology support for clinical trials and the efficacy endpoints for clinical trials themselves could be massively reduced in type and scope, thus leading to uncertainty for patients being treated as well as the healthcare professionals who prescribe the affected products. Although modifications of these requirements could potentially allow for earlier availability of therapeutics to patients, they could also dramatically shift patient exposure to ineffective products, thus sharply reducing their usefulness and cost-benefit and disrupting the financing, resourcing, and eventual success for companies and other Sponsors who discover and develop these products.

The FDA has many programs for accelerated development and patient access to therapeutics that are showing both safety and efficacy potential. These include the treatment IND, single patient compassionate use, emergency IND, EUA, accelerated approval, breakthrough therapy and other designations. These programs have worked well in accelerating the product development process and allowing earlier access to experimental drugs and biologics. A fine-tuning of the system, with evolutionary changes in law, regulation and data requirements, that incrementally impact our entire system of therapeutics is a logical approach to providing access to SAFE AND EFFECTIVE therapies.

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