FDA’s proposals to increase transparency have struck a nerve with medical device makers, and industry association Adva­Med has come out with both fists swinging. In a 21-page letter to the agency, AdvaMed blasts the proposals, many of which involve divulging proprietary information from 510(k) and PMA submissions prior to clearance or approval. Such a move would not benefit the public health and would be devastating for industry competition.
 
AdvaMed’s letter was in response to FDA’s Transparency Task Force’s report issued in May. The association supports a number of FDA’s proposals and draft proposals regarding postmarket transparency. Many of the premarket proposals, however, “would have a negative impact on the public health, innovation, and American competitiveness,” said Janet Trunzo, AdvaMed’s executive vice president for technology and regulatory affairs, in a conference call. “The proposals could create competitive harm, disadvantaging originator companies—especially small companies—relative to their competitors.” Such proposals could end up benefitting foreign competitors, providing them with competitors’ intellectual property and commercially sensitive information—information that has never before been available.
 
This would be a tragic blow to innovation. Trunzo pointed out, for example, that many of the premarket recommendations allow for the release of information during the review process. “The proposed benefit to the public health is that patients would have information about these products,” said Trunzo. “But these are products that are not on the market yet. They’re just in the review process.”
 
Currently the release of such premarket information is protected by law. Trunzo said that implementing several of the transparency recommendations would actually require a change in the statute. “That’s an important fact to know as far as how FDA could move forward with these recommendations,” she said.
 
Trunzo said that AdvaMed is trying to understand the benefit of releasing the information. One of the recommendations suggests releasing request for additional information letters that a submitter of a 510(k) would get in the normal course of review. Trunzo emphasized that—whether the letter was redacted or not—the idea of making that letter publicly available doesn’t really benefit anyone other than competitors. These letters are a back and forth between a company and FDA during the normal course of review. “At least 50% of 510(k)s get a request for additional information letter. That doesn’t mean that a product isn’t going to get approved. It doesn’t mean it’s the end of the line for that company with that product,” said Trunzo. “I see no benefit in releasing that letter even if there were an opportunity to redact it.”
 
What seems so odd about these proposals is that commercial, confidential, proprietary, and trade secret information is currently protected under the law. The release of information about product submissions such as 510(k)s is currently done only after clearance or approval—with the protection of any commercial or confidential information. Releasing information about communications between the agency and the 510(k) or PMA submitter during the review process is inappropriate to say the least. The damage would come in two ways: it would hinder innovation and destroy competition. Such communications with the agency address ethical details in the product submissions, and they often have information about the design of the product or about the clinical trials.
 
This is a dangerous road to go down. AdvaMed put it this way: “The chilling effect on innovation and investment in breakthrough products that would result far outweighs the speculative gains associated with making such information public.” Ditto.

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