Progress Report: How the FDA is Fairing under Trump


Progress Report

How the FDA is Fairing under Trump

This is a follow up to our story on Donald Trump's impact on clinical trials from February 2017.

When President Donald Trump appointed Dr. Scott Gottlieb as Food and Drug Administration (FDA) commissioner, people were concerned that his ties to the pharmaceutical industry might be a factor in keeping drug prices high. Now he has an opportunity to change that perception by correcting some abuses and glitches in the system.

Recently, Dr. Gottlieb outlined plans to bring less expensive medicines to market faster by removing some of the stumbling blocks that generic drug makers encounter. At a public meeting on competition for generic drugs, he related that he plans to streamline the approval process for generic drugs.

He also wants to change the way drug makers use the REMS: Risk Evaluation and Mitigation Strategies system to challenge the safety of generic drugs. When generic drug makers want to make less expensive copies of an existing drug, they can procure letters from the FDA asking the original company to sell them the drug. If, as Dr. Gottlieb proposed, the letters become public, the original companies will have to cooperate in the effort.

Another part of the plan would reduce the time involved in the review process for generic medicines, so that these drugs could get to market faster. Previously, Dr. Gottlieb addressed the overall slowness of bringing drugs to market, but he did not include a plan for making the FDA's communications around rejections of drug applications, called Complete Response Letters, or CRLs, public.

Some observers are wondering why the FDA and other federal agencies have not issued more rulings by now. For instance, pharmaceutical distributors are seeking a rule from the FDA to simplify myriad state rules. Patrick Kelly, executive vice president for government affairs at the Healthcare Distribution Alliance, wrote to the Office of Management and Budget (OMB), “We urge completion of the FDA rule as expeditiously as possible.”

Meanwhile, the FDA announced an indefinite delay in launching nutrition fact labels to let Americans know more about what is in their food.  These labels were intended to indicate “added sugars” and show calorie content in large, bold letters. This program was supposed to take effect in July 2018 and give smaller companies a one-year extension. The FDA also delayed regulations for posting calorie counts on restaurant menus.

Dr. Gottlieb also claimed that the FDA “has struggled to keep pace with its staffing needs as it confronts increasingly complex and specialized products and strong competition from industry for recruiting top talent,” according to an article by Michael Meltzer in Regulatory Focus . According to Dr. Gottlieb, "The first order of business will be to address hiring into the positions supported by our [Prescription Drug User Fee Act] PDUFA commitments. Too many of these positions remain vacant, and the backlog is substantial. Our traditional approach to recruiting and hiring is not as efficient as it should be."

When Trump ran for President, he said the FDA moved too slowly, and drugs were too expensive, according to Meg Tirrell’s report on CNBC. Now Dr. Gottlieb can try to address both issues.



Leave a Comment

Please fill the form below to post a comment.