Right Hooks

Just What the Doctor Ordered

Trump's choice to head the FDA will bring badly needed reform to the agency.

Political Editors · Mar. 14, 2017

As frustration only grows regarding the Republicans’ continued wrangling over how best to repeal and replace ObamaCare, Donald Trump’s choice to head the Food and Drug Administration, Scott Gottlieb, is a needed encouragement. Gottlieb, a physician who has been described as a pragmatist and a policy expert, has a striking resumé and a has written extensively as a resident fellow at the American Enterprise Institute on both the need and the how to reform the FDA’s drug approval processes. Gottlieb is well versed in both the medical needs and the business end of the drug industry. He’s also a cancer survivor, so he knows the personal side too.

A lack of genuine competition within the drug market, specifically regarding production of generic drugs, due primarily to FDA regulations has prevented low cost drug availability. Dr. Gottlieb wrote last year, “Of the more than 1,300 branded drugs on the market, about 10% have seen patents expire but still face zero generic competition. … New regulations have, in many cases, made it no longer economically viable for more than one generic firm to enter the market.”

Maybe the greatest challenge facing Dr. Gottlieb will be changing the FDA culture that, as he has described it, sees itself as the “lone bulwark standing between truth and chaos when it comes to prescription drugs.” This has resulted in the FDA’s drug testing trials becoming increasingly “longer, larger and harder to enroll.” The current average length of a clinical drug testing trial has expanded to 780 days from what was already 460 days in 2005.

Should he be confirmed, Gottlieb would be in a position to roll back these competition-stifling regulations, which can only prove to lower the cost for brand-name and generic drugs. Reforming the FDA would go a long way in helping to cut down on rapidly growing medical costs.

Click here to show comments