In December 1992, FDA promulgated final regulations under which the Agency will accelerate the approval of certain new drugs and biologics for serious or life-threatening illnesses, and when such products provide a meaningful therapeutic benefit to patients over existing treatments. These regulations, which are commonly …
On August 7, 2007, the U.S. Court of Appeals for the District of Columbia Circuit held in Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach in an 8-2 opinion “that there is no fundamental right ‘deeply rooted in this Nation’s history and …
Last week, the U.S. House of Representatives passed H.R. 3161, the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for Fiscal Year 2008. The bill, which, among other things, funds FDA’s discretionary spending for the upcoming fiscal year, “fully funds the …
Legislation that would permit the U.S. Patent and Trademark Office (“PTO”) to exercise discretion to accept untimely filed Patent Term Extension (“PTE”) applications has reportedly been added to the “Patent Reform Act of 2007” (S. 1145) by Senator Edward Kennedy (D-MA). Representative William Delahunt (D-MA), …
Last week, FDA announced the publication of a report by the Agency’s Nanotechnology Task Force (“NTF”) that recommends that FDA develop guidance and take other steps to address regulatory and scientific issues related to nanotechnology. Nanotechnology is an emerging field of applied science and technology …
Every so often something comes across our desk that is so comical that we feel compelled to share it with others in the food and drug community who will also appreciate it. One such story comes from a case involving Biovail and FDA in the …
If so, the Department of Health and Human Services (“DHHS”) is convening a four day stakeholders workshop in Washington, D.C. beginning on July 31, 2007. The purpose of the workshop is to enable stakeholders from government, industry, and academia to discuss the government’s plans to …
FDA has released a new draft guidance for In Vitro Diagnostic Multivariate Index Assays (“IVDMIAs”). The first version, which was released on September 7, 2006, attracted many critical comments. The new draft seeks to address some (but not all) of those concerns. Creating a new …
After a highly anticipated revision of Medicare’s Clinical Trial Policy (“CTP”) that was issued in a July 9, 2007 Decision Memorandum (“Proposed Decision”) left many scratching their heads, the Centers for Medicare & Medicaid Services (“CMS”) issued a Proposed Decision Memorandum for Second Reconsideration of …
Support for legislation that would create a biogenerics approval path is reportedly crumbling. Last month, the Senate Health, Education, Labor, and Pensions (“HELP”) Committee passed S. 1695, “the Biologics Price Competition and Innovation Act of 2007.” Although neither the full Senate, nor the House Energy …
Before you do, be sure to become familiar with the Federal Trade Commission’s (“FTC’s”) regulation of the advertising of such products. Hyman, Phelps & McNamara attorneys Cassandra Soltis and John Fleder noted in an article for the Food and Drug Law Institute’s Update magazine that …
On Tuesday, July 17th, Hyman, Phelps & McNamara attorneys Michelle Butler and Jeff Wasserstein gave a teleconference, titled “False Claims Act Compliance Strategies: Don’t Lose Access to Medicare and Medicaid Reimbursement.” Audio copies of the teleconference, along with a transcript of the witty, yet thoughtful, …
Increasing cooperation between U.S. and European food and drug regulatory authorities are creating efficiencies for regulated industries and that benefit the public health. In two recent press releases, FDA announced that the European Medicines Agency (“EMEA”) has agreed to expand current regulatory cooperation with the …
On July 6, 2007, the Centers for Medicare & Medicaid Services (“CMS”) posted on its website a pre-publication copy of a final rule with a comment period to implement the Medicaid Rebate Program. The regulation, which finalizes a proposal that was published in the Federal …
We previously reported on a proposed rule issued by the U.S. Department of Agriculture (“USDA”) to amend the agency’s National Organic Program (“NOP”) regulations at 7 C.F.R. Part 205 to add 38 non-organic minor ingredients to the National List of Allowed and Prohibited Substances (“National …
