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FDA issues transparency proposals affecting industry



By Colleen Heisey



Published July 9, 2010
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In May 2009, the Transparency Task Force of the U.S. Food and Drug Administration (FDA) released a report outlining 21 specific proposals through which the Agency could increase the transparency of its operations and actions to the public. The report, "FDA Transparency Initiative: Draft Proposals for Public Comment Regarding Disclosure Policies of the U.S. Food and Drug Administration," represents the work of the Transparency Task Force, which was tasked with developing ideas by which to better explain the Agency's actions through the disclosure of relevant information. Promoting "openness in government" is a significant priority in the current administration, and this directive was taken up in earnest by the Department of Health and Human Services. In June 2009, Commissioner Dr. Margaret Hamburg announced the Transparency Initiative, a significant Agency undertaking that led to the development of the recently released draft proposals. In particular, the draft proposals are aimed at illuminating for the public, Congress, media, and industry how FDA operates and why it makes key decisions.

In developing the report, the Task Force undertook a year-long evaluation of current and potential transparency tactics. It conducted two public meetings, took part in listening sessions, created an online blog, and solicited comments from the public. The outreach effort yielded more than 1,500 public comments. In addition, ideas for increased transparency were given extensive consideration and subject to significant discussion within the Agency. The commentary was reviewed by the Task Force, which includes senior Agency leaders, to evaluate how best to balance transparency and confidentiality, culminating in the draft proposals described in more detail below.

The draft proposals generally fall into the following categories: adverse event reports, docket management process, enforcement priorities and actions, import procedures, inspections, product applications (including investigational applications), recalls, and warning and untitled letters. While the draft proposals reported below are categorized according to these groups, the number associated with the specific proposition is included, preceding the summary of the proposal.

Adverse Event Reports

[Proposal 1] FDA should, in conjunction with an appropriate disclaimer regarding the utility of the data, increase public online access to public information from adverse event reports in a searchable database capable of summary report generation.

Docket Management Practices

[Proposal 2] FDA should update its current practices to include posting of comments from individuals submitted by and self-identified as "individual consumer" to www.regulations.gov consistent with its treatment of other comments, such as those from industry, including informing submitters about the public nature of their comments.

Enforcement Priorities and Actions

[Proposal 3] FDA should disclose in the weekly publication FDA Enforcement Report when the U.S. Department of Justice files a case on behalf of the Agency in a court of law as well the final determination of the case. [Proposal 4] FDA should post online all Agency Workplans more than five years old.

Import Procedures

[Proposal 5] FDA should disclose its determinations regarding filer evaluations considering whether filers are submitting accurate and truthful data for importers or third parties working on behalf of importers.

Inspections

[Proposal 6] FDA should disclose details of all inspections of regulated entities and facilities but in a manner that will not disrupt planned enforcement actions. [Proposal 7] The Agency should develop and share information regarding the most common inspectional observations.

Product Applications

[Proposal 8] FDA should disclose the existence of investigational applications, including the name of the applicant sponsor, the date of Agency receipt, the proposed indication or intended use of the product, and the proposed proprietary name of the product, if any. [Proposal 9] FDA should disclose whether investigational applications have been put on hold, terminated, or withdrawn, as well as when an investigational new drug application (IND) was previously placed on hold, whether and when the hold is lifted, including a general statement describing that holds occur for many reasons, only some of which relate to safety or effectiveness. [Proposal 10] FDA should disclose that a new drug application (NDA), new animal drug application (NADA), abbreviated new drug application (ANDA), abbreviated new animal drug application (ANADA), biologics license application (BLA), premarket approval application (PMA), or 510(k) application or supplement was submitted at the time it is received, including the sponsor's name, date of receipt, proposed indication, and proposed proprietary name.

Additionally, [Proposal 11] FDA should disclose when an unapproved NDA, ANDA, ANDA, ANADA, BLA, PMA, or uncleared 510(k) has been withdrawn or abandoned, and if the product is associated with a significant safety concern, a description of the product, the proposed use, and safety concern. [Proposal 12] FDA should disclose when an orphan drug application is withdrawn, based on its review, that the application was not withdrawn for safety reasons and whether the product could represent a significant therapeutic advance. Such disclosure would be accompanied by a disclaimer noting the Agency's comments are not binding. [Proposals 13-15] FDA should disclose when it has issued a refused-to-file or complete response letter for an NDA or BLA, a refuse to approve letter for an NADA, a "not approvable" letter for a PMA, or an "additional information" letter for a 510(k) at the time the letter is issued, along with a copy of the letter containing the reasons for its issuance.

Finally, [Proposal 16] FDA should disclose relevant summary safety and effectiveness information from investigational or pending market applications if it would be in the interest of public health to do so, which includes when FDA believes the release is necessary to correct misleading information about the product. [Proposal 17] FDA should assemble a team of stakeholders, both internal and external, to discuss possible uses of non-summary safety and effectiveness data from product applications and the circumstances under which it would be appropriate for sponsors to disclose such non-summary safety and effectiveness data to the Agency.

Recalls

[Proposal 18] When FDA is authorized to require companies to submit certain information when a company initiates a product recovery or corrective action for a product in the distribution chain, FDA should disclose this information as soon as practicable after receipt. [Proposal 19] Where there is marketplace confusion about products that may be implicated in a food outbreak and information generated by industry or other sources may help alleviate the confusion, FDA should help inform the public about products that are not subject to recall. [Proposal 20] FDA should disclose to the pubic when a recall is terminated.

Warning and Untitled Letters

[Proposal 21] FDA should post untitled letters to its website, including the response to the untitled letter if requested by the responder.

These proposals represent areas where more information would be disclosed than historically has been made public, which is particularly relevant when considering the competitive environment in which new products are brought to market and the significance of the circumstances leading up to and surrounding application submissions. The Task Force explained in the report that while trade secrets are confidential, FDA's current practice is to treat as "confidential commercial information" a substantial amount of information that is submitted to it by companies and that does not meet the definition of trade secret. Such confidential commercial information is not currently publicly disclosed. However, the Task Force is recommending that certain information no longer be considered "confidential commercial information" and the proposals reflect how the Task Force recommends FDA handle this information.

The potential loss of control of proprietary product information for the sake of governmental transparency has not been overlooked by industry groups. While both the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Advanced Medical Technology Association (AdvaMed) have offered general support for the transparency initiative, each has shared some level of concern for the potential to release too much information. In a public statement by AdvaMed, the group noted the positive aspects of increased transparency, but cautioned that companies' proprietary information must be protected, expressing concern over the Agency's proposal to release information regarding applications still under review by FDA. PhRMA's public statement encouraged FDA to carefully consider any proposal to disclose information about products during the review process, citing the need to protect proprietary information and to ensure the competitive development process.

FDA is requesting public comment on the draft proposals by July 20, 2010, particularly regarding whether it has found the proper equilibrium between disclosure and confidentiality while supporting the public health. Additionally, while the Agency acknowledges that not all the proposals will necessarily be put into practice, FDA is requesting input on how the draft proposals should be prioritized for implementation, acknowledging that it will not be able to implement all of the ideas at one time. However, implementation of the proposals may require more than simple public input, given the nature of the information they propose to disclose and the timing of such disclosure. Specifically, current laws and regulations placing certain restrictions on the disclosure of confidential information by the government would likely need amended or the existing interpretations reconsidered. Even the Task Force itself conceded in the report that "[c]hanges to statutes or regulations may be needed to implement some of the proposals."

Colleen Heisey is a partner in the Washington, D.C. office of Hunton & Williams LLP in the firm's Food and Drug Practice. She can be reached at cheisey@hunton.com.


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