Law Firm Pushes FDA to Rethink Limits on Meeting Senior Staff

A law firm that represents drugmakers is urging the FDA to rethink its stance on granting meetings with senior agency officials, saying the existing policy can imperil drug research.

In a submission dated Dec. 7, 2015, the law firm Hyman, Phelps & McNamara contends that recent revisions to FDA policy make it harder for drugmakers to meet with senior agency officials to resolve deadlocks between company officials and division-level agency staff, a process known as Formal Dispute Resolution.

These policy changes stem from an item the FDA inserted into a draft guidance — “Formal Dispute Resolution: Appeals Above the Division Level” — which states that “advice communicated in meeting minutes and general advice letters is not a regulatory action taken by CDER or CBER,” so it does not merit a formal meeting to resolve the dispute.

But according to the law firm, this policy can put companies in a bind because records of division-level meetings — such as minutes or advice letters — are publicly disclosed to investors, which can force companies to either capitulate or else risk spooking investors.

“Our firm has participated in [resolution meeting] processes based, in large part, on positions taken by review divisions in meeting minutes,” the six-page letter states. “We therefore believe this is a substantive change” to the FDA’s process for granting meetings.

One of the letter’s authors, Josephine Torrente, estimates that the issue comes up for clients of the law firm between 20 and 25 times per year.

“The FDA has meetings like this all the time, hundreds and hundreds of chances for a dispute each year,” Torrente said. “It’s a situation that can have a profound negative effect on the development of a drug.”

She explains that these disputes typically center on how best to structure clinical research to ensure approval for a new drug or biologic, but can extend to other scientific topics as well.

Read the letter here: — Cameron Ayers


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