By, Pam Bertani & April Gatling
Recent controversial media attention regarding the alleged misrepresentation and conveyance of pharmaceutical clinical trial results has spawned action in Congress. Currently pending federal legislation could, if enacted, require publicly accessible, detailed disclosure of clinical trial test results for pharmaceutical and biological products. Such a disclosure requirement will undoubtedly have a significant industry and consumer protection impact on the continued development and sale of pharmaceutical products in the United States.
The Fair Access to Clinical Trials Act of 2005 (FACT Act) was introduced by Senators Charles Grassley, R-Iowa, and Christopher Dodd, D-Conn. The goal of the legislation is to ensure that physicians, patients, and the public have full access to information of ongoing clinical trials. The FACT Act proposes to expand the National Library of Medicine’s existing clinicaltrials.gov registry (which currently only lists those clinical trials that test the effectiveness of drugs involving serious or life-threatening conditions or diseases) to include information regarding all clinical trials for drugs, biological products, and medical devices. If enacted, the FACT Act would require the early registration of information including:
-the trial’s title;
-the drug, biological product or device to be tested;
-a trial description in lay terminology;
-the phase of the trial;
-the estimated completion date;
-the study sponsor and study funding source; and
-a full description of the clinical outcomes (both positive and negative).
After the trial is complete, disclosure of trial outcomes and safety data, including data on all adverse events and overall deaths, would be required. The FACT Act also includes hefty sanctions for companies that fail to comply with registration-a civil monetary penalty of up to $10,000 per day, as well as denial of future federal funding for other clinical trials.
Although many well-known pharmaceutical companies have voluntarily pledged to list ongoing and newly accruing clinical trial results on the federal government’s registry or set up their own results databases on the Internet, it has yet to be seen what type of information the companies intend to submit and how useful their alternative sites will be.
Many industry insiders have serious concerns about the pending legislation and the possible business and financial ramifications of being forced to list publicly all ongoing clinical information and outcomes. An early disclosure requirement of the purpose and type of biological product or medical device to be tested gives competing companies a inside glance into otherwise confidential product development. Another significant concern facing pharmaceutical companies is the issue of patent rights. Patents are an important way that companies protect their investment in the development of a new drug. In order to preserve patent eligibility, an invention may not be described in a printed publication or been in public use in the United States more than one year before an application for the patent is filed. Disclosure of the details of a planned clinical trial and registration of crucial information may cause intense confusion when it comes to a drug’s patentability, and ultimately bar the prospect of obtaining patent protection.
The future of this particular bill is yet unknown, as it has since been referred out to the Senate Committee on Health, Education, Labor, and Pensions. What is clear though, is the public’s demand for greater knowledge and additional disclosure when it comes to pharmaceutical drugs and clinical trials. Pharmaceutical companies should take notice.
Pamela W. Bertani is an associate in Weintraub Genshlea Chediak Tobin & Tobin’s Intellectual Property group. Her practice includes providing advice in obtaining various forms of intellectual property protection, including patent, trademark, and copyright protection. Ms. Bertani is a member of the United States Patent Bar, and her practice also includes both patent litigation and prosecution.
April Hiroshima Gatling is an associate in Weintraub Genshlea Chediak Tobin & Tobin’s Litigation and Labor and Employment sections. She represents clients in both state and federal court in complex business, trade secret, and employment related disputes.