Experts Push Back on Provisions in the 21st Century Cures Bill

An initiative aimed at speeding the drug development process to ensure patients have faster access to innovative treatments, several provisions of the bill have received mixed reviews.

"Don’t Weaken the FDA’s Drug Approval Process," screams the title of a blog in The New York Times authored by a formed Comissioner of the FDA and 2 co-founders of a healthcare activist group.

The 21st Century Cures Act, the brainchild of a bipartisan partnership, received overwhelming approval of the House Energy and Commerce Committee about a month back. An initiative aimed at speeding the drug development process to ensure patients have faster access to innovative treatments, several provisions of the bill have received mixed reviews.

In the blogpost, the authors warn against providing access to drugs that have not been thoroughly evaluated for their safety or long-term outcomes, which they say would unnecessarily place the patient at risk. Citing an example of the partnership between AIDS activist groups and the FDA in the 80s, which provided patients with quicker access to experimental drugs, the authors explain that the FDA "transformed itself into a more flexible and creative institution that has introduced new ways to speed lifesaving treatments to patients," while ensuring that the manufacturers monitor drug safety and efficacy. The product of these efforts were the treatment-revolutionizing protease inhibitors that saved thousands of lives.

The authors warn that the Cures bill opens the door to lowering the rigorous standards that the FDA demands manufacturers maintain with their products, that ensure public safety. An example of would be the provision that would allow clinical experience to replace scientific data from large well-controlled clinical trials in the drug approval process. Another example they cite is allowing less rigorous standards for medical devices like heart stents.

Innovation breathes life into healthcare, as has been proven time and again. But innovation without standardization and validation would do more harm than good.