Bradley Merrill Thompson Quoted in Article, “Combination Products: FDA Issues Final Rule on cGMP Requirements for Combination Products, Draft Guidance”

Bloomberg BNA's Medical Devices Law & Industry Report

Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in an article titled "Combination Products: FDA Issues Final Rule on cGMP Requirements for Combination Products, Draft Guidance."

Following is an excerpt:

The Food and Drug Administration is issuing a final rule on the current good manufacturing practice (cGMP) requirements for combination drug-device products, according to a notice published Jan. 22 in the Federal Register (78 Fed. Reg. 4307).

The agency also is releasing a draft guidance for industry on submissions for post-approval modifications to a combination product approved under a new drug application (NDA), biologics license application (BLA), or premarket approval application (PMA). A notice announcing the draft guidance also appeared in the Jan. 22 Federal Register (78 Fed. Reg. 4417).

FDA said the final rule (FDA-2009-N-0435) clarifies which cGMP requirements apply when drugs, devices, and biological products are combined to create combination products. Additionally, the rule includes a transparent and streamlined regulatory framework for firms to use when demonstrating compliance with cGMP requirements for "single-entity" and "co-packaged" combination products, the agency said. ?...

Bradley Merrill Thompson, an attorney with Epstein Becker & Green in Washington, told BNA Jan. 18 that the final rule did not change significantly from the proposed rule and there were "a number of things that could have been clarified."

Thompson said there were a lot of comments on the proposed rule and FDA offered explanations to these comments in the preamble to the final rule, "so you have to refer to the preamble to figure out what it means."

FDA plans to publish another guidance document as a companion to the final rule, which is "where we will find a lot of answers to questions," Thompson said. The final rule "ups the ante on getting the guidance out as soon as possible."

Thompson said companies will need to have systems in shape for when the final rule becomes effective.

Additionally, Thompson pointed out two areas in the preamble where FDA departed from what it has said in the past. Specifically, he said the preamble states that syringes are considered devices and not container/closures. Thompson also said the final rule suggests design controls apply to combination products.

"We're very thankful" that the final rule is out, Thompson said. People at FDA "have been reluctant to talk about combination product cGMPs" and now there is no reason for them not to talk, he said.