Industry Lawyer Urges FDA to Release Combo Product Final Rule

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By Michael Williamson

May 25 — A delayed final rule on postmarket safety reporting for combination drug/device products should be issued as soon as possible, the general council for an industry group told Bloomberg BNA May 25.

Combination products are made up of combinations of a drug, device and/or biological product. They don't fit into the traditional categories of drugs, devices or biological products and are a growing and important category of therapeutic and diagnostic products under the FDA’s regulatory authority.

The proposed version of the rule was issued in 2009. There are two main reasons why it's important that the Food and Drug Administration issue the final rule as quickly as possible, Bradley Merrill Thompson, the general counsel for the Combination Product Coalition (CPC), said.

First, in the absence of a final rule, the CPC has heard that some FDA inspectors have been using inconsistent criteria for inspections of complaint handling and reporting issues, according to Thompson.

“Second, several companies have begun developing and building (or are planning to develop or build in the near future) reporting systems based on their ‘best guess' of what the final regulations will look like,” Thompson told Bloomberg BNA. However, developing combination products without the final rule creates “significant problems” for manufacturers, he said.

The Department of Health and Human Services, in its recently issued spring 2016 regulatory agenda, announced that the final rule (RIN:0910-AF82) would be issued in May 2016.

However, as of May 25, the FDA hasn't sent the final rule to the White House Office of Management and Budget (OMB) for review, which means it is likely that the rule won't be released this month. The OMB reviews rules before they're published in the Federal Register, a process that can take up to 90 days.

The fall 2015 HHS regulatory agenda said the final rule would be issued in April 2016.

2009 Proposed Rule

The FDA issued the proposed version (74 Fed. Reg. 50,744) of the rule in October 2009.

Comments (Docket No. FDA–2008–N–0424) on the proposal were originally due in December 2009. However, the FDA extended the comment deadline until January 2010 (3 MELR 853, 12/16/09) (3 LSLR 1270, 12/18/09) (7 PLIR 1471, 12/18/09) (236 HCDR, 12/11/09).

Thompson doesn't believe the FDA has intentionally delayed releasing the final rule. “I think initially it just wasn't a priority for FDA,” he told Bloomberg BNA. “Sometimes it's that simple. FDA has a lot on its plate, and stuff will simply sit there because other things are deemed more urgent.”

However, the delay may create a risk that the final rule will be outdated once it is released, Thompson said. “There is indeed some risk that it may be outdated simply because the use cases for combination products have expanded significantly. Both the technology and the intended uses of combination products have evolved.”

Impact of Final Rule

The final rule, once released, will have a far-reaching impact on the industry due to the expanding combination product market, according to Thompson.

There are several changes the CPC would like to see to the final rule, because parts of the proposed rule were confusing, Thompson said. For example, the FDA needs to clarify when a combination product maker needs to report adverse events to the agency.

Also, the FDA should better explain what types of events need to be reported in the final version, Thompson told Bloomberg BNA.

Thompson, moreover, said the final rule should clarify and provide more examples of scenarios when duplicate adverse event reports are necessary. In other words, the final rule should describe when separate reports need to be filed for a combination product that is made up of a drug and a device.

The final version also should address implementation, especially for existing combination products, according to Thompson. Manufacturers already have established reporting mechanisms for their combination products and the final rule will present practical challenges, he said.

Thompson also told Bloomberg BNA the final rule should go into effect one year after the FDA issues it.

To contact the reporter on this story: Michael D. Williamson in Washington at

To contact the editor responsible for this story: Brian Broderick at

For More Information

The proposed rule is at

The entry about the final rule in the spring 2016 HHS regulatory agenda is at

The entry about the final rule in the fall 2015 HHS regulatory agenda is at

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