The Supreme Court once famously characterized the risk-benefit analysis for approving new drugs as follows: “[A] drug is effective if it fulfills, by objective indices, its sponsor’s claims of prolonged life, improved physical condition, or reduced pain. . . . [A] drug is unsafe . …
In a previous post, we reported on an assessment conducted by the Analysis Group, Inc. on the effects of authorized generics on paragraph IV patent certifications. There, the authors concluded that “[t]here is no evidence to suggest that authorized generic entry causes delayed generic entry.” …
There is a wise political maxim, “Fool me once, shame on you; fool me twice, shame on me.” Not to be fooled a second time, the U.S. Senate has passed legislation that would, if enacted, make significant changes in the way FDA handles so-called “generic …
We previously reported that Pfizer submitted a citizen petition (2007P-0110) and a petition for stay of action (2007P-0111) requesting that FDA take certain action with respect to Novartis’s LOTREL (amlodipine besylate; benazepril HCl) subsequent to Pfizer’s decision to revoke (as of midnight March 25, 2007) …
Earlier this week, FDA announced the availability of a draft guidance for industry, titled “Bioequivalence Recommendations for Specific Products.” The draft guidance describes a new process by which FDA will provide, via the Internet, recommendations on how to design product-specific bioequivalence (“BE”) studies to support …
On May 22, 2007, the Competitive Enterprise Institute (“CEI”), a self-described non-profit public policy organization dedicated to advancing the principles of free enterprise and limited government, published a report, titled “Healthy Competition: The Case for Generic and Follow-On Biologics.” The report, authored by Gregory Conko, …
On May 10, 2007, FDA announced the availability of a draft guidance for industry –“Protecting the Rights, Safety, and Welfare of Study Subjects – Supervisory Responsibilities of Investigators.” The draft guidance document is intended to help investigators meet their responsibilities with respect to protecting human …
Last Friday, FDA announced the Agency’s plans to take enforcement action against firms marketing unapproved drug products in timed-release dosage forms containing guaifenesin, a commonly used expectorant drug. On May 29, 2007, FDA published a Federal Register notice to this effect. FDA’s latest action is …
In a recently-released report on the pharmaceutical, biotech, and medical device industries’ relationship with FDA, a significant number of representatives surveyed responded that user fees have not succeeded in decreasing approval times. The report, “Improving America’s Health IV: A Survey of the Working Relationship between …
Our colleague John Fleder has just written an article for FDLI Update that outlines the agencies and offices that get involved in decisions to commence FDA enforcement actions, such as Warning Letters, seizures, injunctions (consent decrees), and criminal prosecutions. Mr. Fleder, who used be the …
The Centers for Medicare & Medicaid Services (“CMS”) continues to evaluate and modify, where necessary, Medicare coverage of anti-anemia drugs. On May 14, 2007, after reviewing clinical evidence in peer-reviewed literature and considering concerns raised by a recent FDA advisory panel, CMS issued a Proposed …
West Virginia continues to move forward with implementing its prescription drug advertising expense reporting law. On April 24, the West Virginia Secretary of State filed the West Virginia Pharmaceutical Cost Management Council’s revised emergency rule for Prescription Drug Advertising Expense Reporting. The rule will go …
As we previously reported, FDA’s Division of Drug Marketing, Advertising, and Communications (“DDMAC”) has, in the past year, focused its efforts on ensuring that promotional pieces contain proper presentations of safety data and appropriate efficacy claims. Two new Untitled Letters from DDMAC, however, illustrate that …
The Office of Management and Budget (“OMB”) recently gave clearance for FDA to publish final regulations on current good manufacturing practices (“GMPs”) for dietary supplements. The dietary supplement GMPs are expected to appear in the Federal Register in June 2007, which is over four years …
On May 15, 2007, the U.S Department of Agriculture (“USDA”) issued a proposed rule to amend the agency’s National Organic Program (“NOP”) regulations at 7 C.F.R. Part 205. The proposal, if finalized, would add 38 ingredients to the National List of Allowed and Prohibited Substances …
