Pharmaceutical Research and Manufacturers of America
Dear Mr. Chamey:
The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading research-based pharmaceutical and biotechnology companies, which are devoted to inventing medicines that allow patients to lead longer, happier, healthier and more productive fives. Investing over $24 billion annually In discovering and developing new medicines, PhRMA companies are leading the way in the search for cures. PhRMA is submithng these comments art the proposed revision to OMB Circular A-110.
As it is currently written the Office of Management and Budget (OMB) Circular A-110 provides that the federal government may use or authorize others to use for federal purposes any research data produced under a federal grant. ln winter 1998, Congress added to the 1999 Appropriations Bill (Public Law Number 105-277) a provision requiring OMB to amend the circular "to require Federal awarding agencies to ensure that all data produced under an award will be made available to the public through the procedures established under the Freedom Of Information Act (emphasis added). In response to that provision. OMB published for comment a proposed change to Circular A-110, which governs federal grants for research, that would make certain data relating to research ‘findings available to the public under Freedom Of Information Act (FOIA) procedures.
Under the proposed revision, whenever federally-funded research "findings" have been published and used to develop federal policy/rules, the underlying data would be subject to disclosure under FOIA. Disclosure of this additional research data raises proprietary and intellectual property concerns for research-based pharmaceutical companies.
This proposed revision is of concern to PhRMA member companies because these companies may sponsor or support non-clinical or clinical research that is linked in some way to a federal grant. Interpreting the proposed revision very broadly, a possible example of a link between this type of research and federal funds might be a clinical trial collaboration between a company and a National Cancer Institute (NCI) cooperative group. Additionally, an academic researcher " who may make a confidentiality commitment to a company in exchange for some type of research support " may also be receiving federal funds for the same general area of research. In both cases, if the published results were cited by the government to support some federal program or rule, Circular A-110 could be interpreted to require disclosure of the underlying raw data, despite an agreement between the company and the collaborator to keep that information confidential. In these examples the company would rely in part on the FOIA exemptions to protect its trade secrets (see item 2, below); nonetheless, significant uncertainty remains, uncertainty that could stifle future research efforts.
Companies may also provide a supply of a drug to federal entities such as the NCI and other investigators (some of whom may be receivng federal grant money). Under certain circumstances, a PhRMA member may allow NCI and other investigators to cross-reference the company’s Investigational New Drug (IND) applications and provides authorization letters to reference the company’s Drug Master Files. If such activities could expose the PhRMA member company’s information to public disclosure, the company would have to weigh the reasons for such cooperative efforts against the prospect of having to defend against the applicability of the OMB Circular, or to assert an exemption from FOIA against a request for the data. Such efforts would divert significant resources (personnel and time) from productive activities to protect against disclosures which exceed the original intent of the Congress.
PhRMA member companies are also involved in epidemiological research intended to address important public health issues. For example companies participate in large observational studies (often funded by the federal government) that are expected to influence public health policies. Such studies are often designed to answer a series of questions over an extended period of time. If the publication of research findings for one question triggers a broad disclosure of underlying data pursuant to the OMB Circular, the study’s ability to answer the remaining research questIons may be compromised or negated. Thus, the opportunity for researchers to study these unanswered questions, and publish their findings and analyses, may be jeopardized.
Epidemiological research often entails collecting comprehensive and detailed personal information about study subjects. Due to this concern, epidemiological data is typically disclosed in an aggregate form unless there is a demonstrated need to access individual data. The lack of clarity in the proposed language, coupled with uncertainty about how individual federal agencies might interpret this language, leads to a legitimate concern that there will be substantial confusion in the research and patient communities. It is reasonable to expect that patients will be less likely to participate in epidemiological research if the safeguards for their sensitive personal information are unclear or the confidentiality of their information hinges on the timely application of a FOIA exemption.
PhRMA has four general comments and recommendations for the proposed revision to Circutar A-110 to accommodate the change imposed by the language in the 1999 Appropriations Act.
1. Policy or Rule Limitation
The proposed Circular states that the FOIA provision would apply to data used in developing a federal government policy or rule. This is based on the apparent decision by Congress that the public should have access to data used to make decisions of general applicability, e.g., to set pollution control standards, or standards for approval of prescription pharmaceuticals. It is also important to recognize, however, that private parties have a strong interest in maintaining the confidentiality of proprietary information, e.g., clinical trial data.
The proposed revision to Circular A-110 does not contain a definition of either "policies" or "rules," but the definition of both of these terms is central to the clarity, and therefore usefulness, of the Circular. The omission of definitions for these terms creates the potential for confusion and therefore invites litigation about what studies or what data are encompassed by the revised Circular A-110.
A limited definition of "policy" and "rule" would be consistent with apparent Congressional intent, which was to make available to the public and regulated industries the data on which major policy choices are made, not the data supporting each and every application of government policy decisions to specific individual cases.
A broad interpretation of the terms "policy" and "rule" would discourage or delay publication of research findings. Scientists who want to maintain the confidentiality of research data, regardless of the reason for the interest in confidentiality, will attempt to maintain that confidentiality. They are not likely to have much control over the way that a federal agency uses the results of published studies. They do, however, have some control over when they publish research results. Researchers may be encouraged to delay publication until all planned analyses are completed, so that they can avoid a request for access to the data.
PhRMA recommends that OMB incorporate into Circular A-110 a definition of "policy" and "rule" stating that a policy or rule is one that is established through notice and comment rulemaking. ThIs would tie the definition, and therefore the reach of the Circular, to those instances where the agency determined that its decision had general applicability. It would also allow OMB, researchers and research institutions, and the public to be clear about what types of government decisions constitute "policy" decisions or "rules."
In addition, PhRMA recommends that Circular A-110 be revised to explicitly exclude from the definition of a "policy" or a "rule" all decisions by FDA that apply an established rule to an individual case, including approval of a new drug application based on the application of FDA’s "rule" or standard for approval. Such a limitation would safeguard the confidentiality of information submitted by private parties in new drug applications and supplemental applications.
2. Application of FOIA Exemptions
OMB’s proposed revised Circular A-110 is not entirely clear that all of the current exemptions from FOIA still apply, e.g., the exemption for confidential commercial infomation. While the accompanying discussion explicitly states that the FOIA exemptions apply to any data submitted to a federal agency in response to a FOIA request under the revised Circular, the language of the proposed revised Circular does not explicitly state that the exemptions will apply to data submitted in response to an agency request made under the revised Circular.
The legislative history makes clear that the appropriations rider was intended solely to circumvent Forsham v. Harris. Thus, the change was intended not to compel automatic disclosure of the data, but rather to require grant recipients to agree to submit data to the funding agency for FOIA review. The limited debate on the appropriations rider does not indicate that Congress intended to make any changes in the FOIA exemptions or in their applicability to the research data underlying any government decision.
Although courts will ordinarily also look to an agency’s contemporaneous explanations when interpreting regulatory provisions, the actual Circular should provide more explicit assurances that FOIA exemptions continue to apply.
PhRMA recommends that the final revision to Circular A-110 contain an expliclt statement that the standard FOIA analysis of potential exemptions must be applied prior to any disclosure of research data to a third party. A contrary interpretation would, in many instances, render the FOIA exemptions meaningless.
The proposed language in Circular A-110 about the scope of the provision (e.g., "data relating to published research findings") is vague, and consequently how the amended OMB Circular would be interpreted and applied is not clear. The Circular also appears to reach data "relating" to findings produced under an award, while the 1999 Appropriations bill authorizing the circular was expressly limited to "data produced under an award."
With collaborative research programs, conducted with funding from both government grants and non-government funds, it may not be clear which data were produced under the government grant and which data were produced from the private funding. If a researcher uses a government grant to re-analyze data generated through private funding, it may not be clear whether the data are reachable under Circular A-110.
PhRMA recommends that the Circular be revised, consistent with Congressional intent, to apply solely to data produced under an award, not data "relating to" other data produced under an award from a federal agency.
4, Prospective Effect
The appropriations rider does not amend the Freedom of Information Act. Rather, it directs OMB to require that federal agencies awarding grants ensure that the federal government can obtain from the grantee, in response to a request by a third party, data generated as a direct result of the grant. An agency cannot force grant recipients to submit data unless access to such data is required as a condition of the federal grant. For grants made prior to passage of the appropriations rider, agencies have no mechanism to impose new conditions. Any attempt to impose such a disclosure requirement retroactively would raise numerous due process, government grant procedure, and takings clause questions.
Retroactive application would also represent poor public policy. Application of the revised Circular to grants made prior to promulgation of the final revised Circular would be fundamentally unfair to recipients who accepted grants with the expectation that they would be able to maintain control over research data. In addition, attempts to force disclosure of data produced with grant funds awarded before the revised Circular is finalized would disrupt scientific inquiry. Competitors, adversaries in litigation, and political opponents would be able to use FOIA requests to interfere with research that is in final, i.e., analysis and report publication, stages.
Collaborative research projects may also suffer as a result of worry about the scope of the releasable data under the proposed Circular. For example, if a government grant funds the re-analysis of data collected through private funding, it is not clear whether the data would be subject to release under the proposed revised Circular. If the revised Circular applies solely to new grants, grantees can clarify, before accepting a grant, the scope of t