The National Institutes of Health (NIH) Office of Biotechnology Activities proposes revising the “NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules” “to streamline review of certain human gene transfer trials that present a low biosafety risk.” The types of trials that may qualify for an exemption from further institutional biosafety committee review include those involving gene transfer products either frequently used over a number of years or of sufficient low biosafety risk. Comments are requested by June 12, 2013.
The Office of U.S. Trade Representative issues a “Special 301” Report that highlights concerns about the recent decision by India’s Supreme Court “with respect to India’s prohibition on patents for certain chemical forms absent a showing of ‘enhanced efficacy,’” which apparently earned India a place on the U.S. “priority watch list,” characterized in the media as a “special trade blacklist.” According to the report, “the decision appears to confirm that India’s law creates a special, additional criterion for select technologies, like pharmaceuticals, which could preclude issuance of a patent even if the applicant demonstrates that the invention is new, involves an inventive step, and is capable of industrial application.”
The Food and Drug Administration issues guidance for industry and agency staff titled “Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data.” Comments may be submitted at any time.
U.S. Senators Amy Klobuchar (D-Minn.) and Bob Casey (D-Pa.) call on several pharmaceutical companies to “boost production to end the current shortage of critical drugs used to treat infants in intensive care.” According to their May 3, 2013, letter, the shortage involves drugs that provide nutrition to premature and critically ill infants.