This weekly post summarizes selected regulatory events from the previous week. This post is not a complete summary of FDA activities.
Arsenic in Rice: On Tuesday, July 2, the Chicago Tribune reported that the Illinois Attorney General had sent a letter to FDA asking why the agency has not taken action on 2012 tests on arsenic levels in rice. FDA had said in a September 9, 2012 consumer update that it was not recommending any changes to rice consumption, and that it had “been monitoring arsenic levels in rice for more than 20 years.” FDA said its recent round of testing “thus far does not show any evidence of a change in total arsenic levels,” but that once it “has completed its analysis of about 1,200 rice products, the agency will analyze these results and determine whether or not to issue additional recommendations.”
Antibiotic Guidance: On Monday, July 1, FDA released draft guidance on “Antibacterial Therapies for Patients With Unmet Medical Need for the Treatment of Serious Bacterial Diseases.” The draft guidance is in response to the increasing prevalence of drug-resistant bacteria and the declining rate of new antibiotics coming to market. FDA proposes “streamlined” approaches to antibiotic clinical development. Comments are due November 1, 2013.
Privacy of Research Misconduct Investigations: Also on Monday, July 1, FDA reported that Secretary Sebelius had reinstated a rule exempting certain records about research misconduct probes from Privacy Act disclosures. FDA said that the exemptions “are essential in order for FDA to protect the confidentiality of sources who provide information relevant to a research misconduct proceeding and to guard against the premature disclosure of research misconduct records that might obstruct or compromise proceedings.” The Federal Register Notice is available here.