Inside Health Policy Quotes Eli Tomar on FDA’s University Research Studies for Compounding

Eli Tomar, counsel in the health care and life sciences practice at Akin Gump, has been quoted in the Inside Health Policy article “FDA Notifies OMB Of Compounding Research With Maryland, Hopkins.” The article reports that the Food and Drug Administration has told the White House it intends to work with large research universities to evaluate whether a clinical need exists for certain bulk drug substances to be compounded at outsourcing facilities.

According to the article, the FDA announced last September a study with Johns Hopkins University (JHU) that will focus on evaluating the effectiveness of six bulk drug substances used in compounded drugs to treat autism spectrum disorder. A separate study with the University of Maryland (UMD), the article notes, will look at how drugs compounded with bulk drug substances are used in clinical practice, and how they have been used historically. The research agreements are the second of a two-part process to evaluate the clinical need for bulk drug substances.

“FDA is doing that analysis itself so it will only work with UMD and JHU on substances that clear the first step and for substances that are not components of approved drugs,” explained Tomar.

Tomar said the notice to the White House is perfunctory under the Paperwork Reduction Act, though the research studies could be an important development. The FDA could have consulted with its own advisory committee on the subject, he said, but these studies could allow it to tap into expertise at the two universities that the agency may not have had access to otherwise.

The notice comes at a contentious time in FDA’s efforts to oversee compounding, the article reports, with it having barred two bulk substances from the process. Tomar suspects a third one is going to be analyzed soon by JHU. He also expects more friction from compounders in the future, regardless of the research studies conducted to inform the agency’s decisions.

“At the end of the day, detractors of FDA’s decision (whether the decision is to include or exclude a substance) on the 503B bulks list are likely to be critical of this process,” Tomar said.