The Food and Drug Administration has given manufacturers of coronary drug-eluting stents a look at what kind of safety and effectiveness data it will be seeking in the future—and the industry does not appear to be taken aback by what's in the 89-page document.
“This draft guidance is part of FDA's ongoing effort to provide regulated industry with recommendations on measures that can minimize the risks while preserving for patients the benefits of drug-eluting stents,” said Dr. Daniel Schultz, director of the FDA's Center for Devices and Radiological Health, in a statement accompanying the document's publication.
The draft gives recommendations on assessing the toxicity of drug coatings, both on their own and as part of the stent product, according to the agency. Most of the guidance pertains to metal drug-eluting stents; there is less complete information provided on stents made from other materials, such as ceramic or polymer.
The document clearly states an expectation of postmarketing studies out to 5 years after approval. The proposed “guidance,” if made final, would not carry the weight of a regulation.
The guidance is a departure for the agency, as it combines the efforts of the drug and device divisions. “This guidance demonstrates how FDA will need to work across traditional product boundaries to guide the development of innovative new products,” said Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research, in the statement.
Dr. Christopher White, chairman of the department of cardiovascular diseases at Ochsner Clinic Foundation, and a principal investigator for several stents, views the FDA guidance as a positive development. “The fact that FDA is willing to commit on paper the core elements of what they view as necessary for device approval is actually very helpful,” said Dr. White in an interview.
He said that the draft does not seek much that companies are not already doing—with the exception of long postmarketing data—and it will take a while to be put in place.
A Boston Scientific Corp. spokesman agreed that its pipeline would likely not be affected. In any case, Boston Scientific has already been collecting 5 years of postmarketing data on its products, said the spokesman.
The FDA will accept comments on the guidance through July.