FDA Week Quotes Eli Tomar on FDA’s Regulation of Compounded Drugs
Eli Tomar, counsel in the health practice at Akin Gump, has been quoted extensively in the FDA Week article “Stakeholders Expect Flurry Of Compounding Action, Hope For Policy Fixes.” The article looks ahead at the FDA’s efforts this year to implement the Drug Quality and Security Act (DQSA), a law that gives it greater authority to regulate and monitor the manufacturing of compounded drugs.
The article reports that the FDA is facing pressure on both sides of the compounding debate. On one side are those who are pushing for a more stringent policy on bulks and a holding-of-the-line on office-use compounding. On the other side, according to the article, are those pushing for looser restrictions on traditional compounders who want to make drugs in advance of a patient prescription.
For his part, Tomar said, “I hope that they do a lot on compounding [in 2018].” He added that detractors incorrectly say FDA is abandoning implementation of the DQSA. He also noted that FDA needs to “get some of these things to the finish line and start enforcing it.”
Predicting that the FDA will have to balance the views of many factions, Tomar said, “If you’re a betting person you’re trying to align where Congress is asserting the most pressure, what is [FDA Commissioner] Gottlieb’s agenda and how does that at least overlap in some way with what the [Center for Drug Evaluation and Research] compounding team wants to do.”
Tomar also sees the FDA as being likely to act on DQSA’s bulk substance and essentially copies of approved drug products provisions. He emphasized that the FDA is probably looking to finalize the “essentially a copy” guidance before it is interpreted by the court at the center of related litigation.