Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Regulatory Affairs Professionals Society (RAPS), in “Devices Referencing Drugs: Questions Raised Over Potential Regulatory Pathways,” by Michael Mezher.
Following is an excerpt:
The US Food and Drug Administration (FDA) on Thursday held a public hearing to look into the scientific, regulatory and legal challenges posed by devices referencing drugs (DRDs) and the agency’s proposed approach to regulating such products. …
But Bradley Thompson, a regulatory attorney with Epstein Becker & Green who spoke on behalf of the Combination Products Coalition, cautioned that if FDA were to make the regulatory pathway for DRDs too easy it could discourage collaboration.
Thompson also raised the point that FDA already has standards for determining whether combination products are regulated as drugs or devices, and said it would be unfair to treat all DRDs as devices.
“If there’s a drug primary mode of action, if the issues are drug related issues, if its proving the safety and effectiveness of the drug because they can’t use the data from the pharma company, that’s a drug submission, it’s [a new drug application] NDA,” Thompson said.
