· 6 min read
The U.S. Food and Drug Administration's plans to transition certain products regulated as drugs to device status are causing concern in the pharmaceutical sector. What is happening, and what can you do if your product is impacted? Andrew Papas, Vice President of Pharmaceutical Services Regulatory Affairs at NSF, looks at this issue.
In August 2021, the agency announced in a Federal Register notice that it would be publishing a list of drug products that it determined should be reclassified as medical devices. The decision was made based on a legal case in the U.S. Court of Appeals, DC Circuit Court of Genus Medical Technologies LLC v. the FDA.
The case centered on a ruling that the FDA does not have the sweeping discretion to classify a product (barium sulfate, in this case) that meets both the definition of a drug and a device automatically as a drug. The agency's preference to classify borderline products as drugs has brought about this change.
Media reporting on the issue has centered on companies looking to market ophthalmic products that are especially impacted by the decision and imaging agents. However, industry bodies report widespread confusion and alarm at the changes and the lack of due process in transitioning drug products to medical device status.
Companies with products that fall within the transitional combination product issue should prepare for further information requests from the agency. They should also prepare for notifications of deficiencies or other communications.
The pharma industry, and many of its trade bodies, have been vocal in their denouncements of the move. Some have pointed to the FDA's decision to apply the ruling retroactively. This, they argue, will force companies to comply with a new set of requirements. Furthermore, this might threaten the availability of products in the market as companies deal with transition issues.
As referenced above, companies impacted by this decision will need to prepare for a dialogue with the agency. A reclassification from a drug product to a device product will affect facilities, product labeling and storage issues. Furthermore, reclassification from drug to device might impact some company's exclusivity designations.
We can assist companies dealing with this issue. The FDA ruling has impacted many companies, and our team of ex-FDA executives and industry experts can help ensure that your product is correctly classified.