POSITION STATEMENT OF THE AMERICAN ASSOCIATION OF PHARMACEUTICAL SCIENTISTS ON OMB CIRCULAR A-110

The American Association of Pharmaceutical Scientists (AAPS), founded in 1986, is a group of more than 10,000 pharmaceutical scientists who have joined together with the mission to serve the pharmaceutical sciences, promote the economic vitality of the pharmaceutical sciences, and scientists, and represent pharmaceutical sciences interests within academia, industry, government and other private and public institutions.

OMB CIRCULAR A-110 BACKGROUND INFORMATION

During congressional debate on the FY99 omnibus appropriations bill (P.L. 105-277) in October 1998, Senator Richard Shelby (R-AL) sponsored an amendment requiring government agencies to make federally funded research and data available to the public. Specifically, the Shelby amendment directed the Office of Management and Budget (OMB) to modify OMB Circular A-110 to require federal agencies to ensure that all data produced under grants made to institutions of higher education, hospitals, and non-profit organizations be made available to the public through procedures established under the
Freedom of Information Act (FoIA). On Nov. 8, 1999, OMB Circular A-110 was published in its final form (after two proposed revisions on Feb. 4, 1999 and Aug. 11, 1999). In an effort to help scientific communities understand how OMB Circular A-110 will impact researchers, the National Institutes of Health (NIH) has issued a preliminary implementation statement to grantees and applicants. The revised final version of OMB Circular A-110, "Uniform Administrative Requirements for Grants and Agreements with Institutions of Higher Education, Hospitals, and Other Non-Profits Organizations," was published in the Federal Register, vol. 50, No. 52, on March 16, 2000 under Rules and Regulations. AAPS has produced the following position statement on OMB Circular A-110:

AAPS POSITION

While AAPS supports the effort to encourage open dialogue and access to publicly funded research, we believe the Shelby amendment, notwithstanding the current OMB revisions, is too broad, subject to misinterpretation, and beyond the scope of the intention of what would be considered a reasonable
effort to ensure public access to data produced using a federal grant.

A strict interpretation of the Shelby provision could have lasting negative implications for science. For example, pharmaceutical companies support certain areas of research interests at academic institutions which, in turn, receive federal funding for other aspects of the same programs. If this data is required to be made available it could result in the premature release of raw data considered proprietary by the sponsoring party and could breach contractual obligations between the parties. Allowing access to raw data and patient records could inappropriately disclose confidential medical information of patients, breaching the protection of human subjects in medical research.

There are also cost and human resource implications which need to be considered. Despite the "reasonable cost" provisions in the amendment, clearly, valuable time and energy would be taken away from research efforts by fulfilling potentially limitless requests for data. Because there are no
limits in the Shelby amendment to potential requests for information, it is possible that the time of a talented researcher, looking for complex answers to heart disease, AIDS, or other illnesses, could be primarily dedicated to responding to federally sanctioned requests for information.

AAPS believes that the revisions to Circular A-110 made during the regulatory implementation of the Shelby amendment, as well as the preliminary guideline published by NIH in its "NIH Grantees and Applicants: Notice of amendment to Circular A-110" have temporarily mitigated some of the potential negative impact of the legislation. However, there are two major concerns which point up the need for a more permanent solution. They are: A change in presidential administrations, such as the one which will
occur in 2001 could dramatically alter the manner in which the Shelby legislation is interpreted and implemented. This uncertainty would most certainly be chaotic for the scientific community and could lead to poor value for federal research dollars.

In the courts, proponents of the Shelby amendment are already litigating against federal agencies which they believe do not comply with this law. Regardless of the revised OMB Circular A-110, if they sue and win, the scope of the Shelby amendment could be limitless. Research and the scientific community would be compromised.

It is for these reasons that AAPS supports responsible legislative action to modify the scope or repeal the Shelby FoIA provision of P.L. 105-277.

In the 106th Congress there are two bills pending which would repeal the FoIA provisions of P.L. 105-277. The late Congressman George Brown (D-CA), introduced a bill, H.R. 88, that would repeal the FoIA provisions in P.L. 105-277, on the grounds that it is "both flawed by [the] process through which it was adopted and because of the damage it is likely to do to the publicly funded research structure which we have developed over the past fifty years." Senator Daniel Patrick Moynihan (D-NY) introduced S.1437, a
bill that would also repeal the law. Currently, both of these bills are pending in committee. Furthermore, there is discussion of another bill being introduced by Senator Durbin (D-IL) that would modify the legislation in a way that is similar to the existing regulatory interpretation and implementation of the Shelby provision. The legislation would codify the OMB and NIH interpretation of the Shelby amendment. AAPS is supportive of all of these legislative solutions.