The Food & Drug Administration is proposing to expand the amount of information it reveals about its approvals process for medical devices and drugs, including revealing applications for investigational device exemptions and when it denies applications.
The 21 proposed changes, released May 19, are already drawing fire from industry. AdvaMed, the national lobby for the medical devices industry, said the proposed changes would weaken intellectual property protections and stifle innovation.
Specifically, the proposals call for the federal watchdog agency to reveal when companies file for investigational device exemptions, 510(k) clearances and pre-market approvals "and, when asked, confirm the existence or non-existence of investigational applications" or whether they’ve been terminated or withdrawn. The proposals also call for the FDA to disclose when it denies PMA or 510(k) applications and to detail the reasons behind the denial. And if it deems it beneficial to public health, the agency would release "relevant summary safety and effectiveness information" from IDE or pre-marketing applications, "which includes when FDA believes it is necessary to correct misleading information about the product."
AdvaMed executive vice president for technology and regulatory affairs Janet Trunzo said in prepared remarks that the move to increase transparency "raises concerns."
“The world-leading U.S. medical technology industry is highly competitive and disclosing the existence or other key details of a manufacturer’s IDE or marketing application could publicly reveal important intellectual property and other information which could put companies at a disadvantage without any countervailing public safety benefit," Trunzo said.
“Weakening intellectual property protections is a dangerous recipe for stifling investment in breakthrough products and could significantly impede medical progress and ultimately impair public health. We look forward to working with FDA to address this issue.”
The FDA countered that the new disclosure policies would not put companies at a competitive disadvantage, arguing in the case of IDE’s that "[d]isclosing the fact that FDA has received an investigational application will not allow a competitor to copy the formulation of a product or reverse engineer a device. The potential availability of a new product on the market is not the only basis on which products compete; for example, improved effectiveness of the product, fewer side effects, and easier use by the patient are among factors that differentiate products on the market."
Similarly, the agency argued, "[p]roviding the status of the clinical trial does not disclose information that could be used by competitors to ‘free-ride’ off of the sponsor’s innovative effort. In some cases, the existence of human clinical trials is already public."
As for disclosing when applications are denied or withdrawn, the agency pointed out that, while its current regulations prohibit that disclosure, the information is disclosed in Europe.
"This disparate treatment is not merited, given the global nature of the regulated industry, and does not further the Administration’s goal for more open government," the agency said.
Disclosure of clinical trial data is another matter, the FDA conceded.
"The disclosure of all data from ongoing trials or from pending marketing applications, before the company has had an opportunity to use those data to obtain approval of the product, may negatively affect product development. Disclosure of certain information, at the wrong time, may have the unintended consequence of slowing, or even stifling, product development," it reasoned. "Blanket protection of all information in pending product applications, however, has not been shown by industry to be economically necessary, in light of other legal protections provided for innovative research (e.g., patent and unfair competition laws, exclusivity periods provided innovator drugs). Further, the impact on a company’s competitive position may cut both ways — disadvantages to one product line may be more than compensated for by the overall benefits to a company. And there are public benefits to be gained by the disclosure of safety and effectiveness information, including in the advancement of science, protection of patients that may use these products, and the efficient use of limited resources available for research. … The correct balance is to allow FDA to disclose a summary of safety and efficacy information, when it determines the information is necessary to protect the public health."
Here are the details on some of the proposals:
- FDA should disclose the existence and, when asked, confirm the existence or non-existence of investigational applications. For investigational applications, the disclosure should include the name of the application sponsor, the date the application was received, the proposed indication(s) or intended use(s) of the product, and the proposed proper and/or trade name of the product, if available. Read the reasoning for this proposal and comment
- FDA should disclose: (1) whether an investigational new drug application (IND) has been placed on hold, terminated, or withdrawn, whether an investigational device exemption (IDE) has been terminated or withdrawn, or whether an investigational exemption for a new animal drug has been terminated and (2) if an IND has previously been placed on hold, whether and when the hold is lifted. A statement should be included that such actions may be taken for various reasons, only some of which relate to safety or effectiveness. Read the reasoning for this proposal and comment
- FDA should disclose the fact that an NDA, NADA, ANDA, ANADA, BLA, PMA, or 510(k) application or supplement was submitted (or resubmitted) to the Agency at the time the application is received by FDA. The disclosure should include the name of the application sponsor, the date the application was received, the proposed indications or intended use of the product, and the proposed proper and/or trade name of the product, if available. Read the reasoning for this proposal and comment
- FDA should disclose that an unapproved NDA, ANDA, NADA, ANADA, BLA, or PMA, or uncleared 510(k) has been withdrawn or, if FDA determines that the application was abandoned, abandoned by the sponsor. If the drug, biological product, or device is associated with a significant safety concern, FDA should provide a brief description of the product, the use for which approval was sought or obtained, and the identified safety concern. Read the reasoning for this proposal and comment
- FDA should disclose the fact that the Agency has issued a “not approvable” letter in response to a PMA for a medical device and the fact that FDA has issued an “additional information (AI)” letter in response to a 510(k) submission, and should, at the same time, disclose the reasons for issuing the “not approvable” letter or “additional information (AI)” letter, which contains the reasons for issuing the letter. Read the reasoning for this proposal and comment
- FDA should disclose relevant summary safety and effectiveness information from an investigational application, or from a pending marketing application, if the Agency concludes that disclosure is in the interest of the public health, which includes when FDA believes it is necessary to correct misleading information about the product that is the subject of the application. Read the reasoning for this proposal and comment
- FDA should convene a group of internal and external stakeholders to discuss the possible uses of non-summary safety and effectiveness data from product applications, the circumstances under which it would be appropriate for sponsors to disclose non-summary safety and effectiveness data from applications submitted to FDA, and if appropriate, the format and the method by which disclosure should occur. Read the reasoning for this proposal and comment