Regulators Offer Tips on Comments, Communications

Devicemakers finding themselves having to change postmarketing requirements or other commitments need to inform the FDA and other regulators as soon as possible if they identify gaps in their plans.

Indeed, there’s nothing worse than sticking to a path a company knows won’t work, according to Kim Trautman, associate director of International Affairs, Office of the Center Director within in the FDA’s device center. “It just tells me that the people who did the original submission didn’t know what they were doing,” she added.

Trautman made these remarks during a standing room-only session at the Regulatory Affairs Professional Society Convergence Conference in Baltimore, Md., last week that featured consultants, an industry representative and regulators from Japan, Korea, Austria, Germany, the European Medicines Agency and the FDA. There were no formal presentations, but members of the drug and device industries were allowed to ask questions as they sought clarification.

If a sponsor must change something, it should make an amendment to the commitment justifying why it needs to make the adjustment. Failure to do so in a timely manner makes it seem as if you’re pushing it off, Trautman added.

“Updating is not unusual,” added Andrea Chamblee, adjunct professor, George Washington University School of Medicine and Health Sciences and Johns Hopkins University, referring to supplements in the postmarket setting. Still, many stakeholders fail to make needed changes in a timely manner.

When asked whether informing the FDA that a product has received a positive review in another jurisdiction would have an effect on the eventual decision, Trautman urged caution. “It’s how you present it,” she noted, but warned the audience not to play the agencies off against each other. She added that sponsors may want to consider concurrent reviews, allowing them to speak with regulators from multiple jurisdictions on the phone at the same time.

Andrea Laslop, head of Scientific Office at the Austrian Agency for Health and Food Safety, said the CHMP never ignores an FDA approval, but disease treatment approaches in the two regions differ. It’s rare for a medical product to be approved in both jurisdictions concurrently. Laslop and Trautman agreed that withholding information from one regulator was a big no-no.

“It will come out,” said Trautman, who added that she traveled for about 70 percent to 80 percent of her job and is constantly on the phone with other regulators. Not disclosing something will just make it worse for the company.

Sabine Haubenreisser, EMA liaison at the FDA, said the earlier stakeholders discuss issues with regulators, the better, as the agencies may be able to have a dialogue about the products in question and arrive at some sort of consensus.

Combination Products

When a company wants to develop combination products, Trautman urged early communication with the FDA. Specifically asked about a device-related change when the drug is the primary mode of action for the product, Trautman emphasized that it is essential to inform both drug and device centers of the change to head off any problems down the road. “Combination products are still struggling to find a consistent path,” she noted, so transparency is essential.

Trautman also addressed communications with the FDA, after one participant said she had spent months trying to get an answer. “Yes, we do have a bureaucracy,” joked Trautman, “but sometimes, we feel a little abused.” Reviewers may be bombarded with questions, just as they are trying to meet mandated MDUFA time lines and other performance goals.

“Don’t use us as informal consultants,” she said. However, if a company believes it has a legitimate question and is not getting an answer, it should take it to the office or program level of the agency.

Ultimately, if the company doesn’t get a response in a timely manner, it may contact the appropriate center ombudsman, whose job it is to bring about resolutions for complaints. Trautman told the audience not to be afraid to use the available avenues at their disposal to get a response, as the agency is aiming to have more open, informal communications with stakeholders.

The session concluded with a question on inspections and what to do if the company and the auditor are at odds over terminology. Trautman advised attendees not to change wording to satisfy an auditor’s perceived want or need. Certain terms may have a particular meaning, such as validation — notified bodies and the FDA have different thought processes about that word. In those cases, it’s better to be precise; in others, companies should do what’s best for them. — Elizabeth Hollis