When Hyman, Phelps & McNamara, P.C. launched the FDA Law Blog 2 years ago today – Is that 14 in “blog years”? It certainly seems like it, if not more! – we could hardly imagine how successful it would become and how our subscribers (and the …
Menu
Hyman Phelps McNamara
- FDA Law Blog Turns Two “Blog Years” OldMarch 6th, 2009
- Indiana Joins NYC’s Efforts to Combat Obesity; House Passes Menu Labeling BillMarch 6th, 2009
By Cassandra A. Soltis – The Indiana Senate is currently reviewing House Bill No. 1207, passed by the House on February 25, 2009, which would require food establishments having 20 or more locations in Indiana to post both calorie and carbohydrate information “in a manner that …
- Introducing the FDA Law Blog REMS TrackerMarch 5th, 2009
By William T. Koustas – As we have previously reported, Title IX of the Food and Drug Administration Amendments Act of 2007 (“FDAAA” or “the Act”) provides a new statutory framework and authority for FDA (or “the Agency”) to require Risk Evaluation and Mitigation Strategy …
- FDA Receives a 4th Citizen Petition on QI Act and 30-Month Stay Issues; Latest Petition Concerns EVOCLINMarch 5th, 2009
By Kurt R. Karst – Last week, we reported on the third citizen petition submitted to FDA requesting that the Agency address whether the 30-month stay provisions of the Hatch-Waxman Amendments apply to a pending ANDA for a generic version of an old antibiotic drug, …
- U.S. Supreme Court Issues Decision in Wyeth v. Levine; Court Rejects PreemptionMarch 4th, 2009
By Kurt R. Karst – Earlier today, the U.S. Supreme Court issued its highly anticipated opinion in Wyeth v. Levine. By a 6-3 vote (Justice Alito, Chief Justice Roberts, and Justice Scalia dissenting), the Court ruled that FDA labeling approval does not preempt state laws. …
- FDA Confirms that the Term “Dietary Supplement” Is a Legal Statement of Identity for Dietary Supplement Products and that FDA Guidance to the Contrary is in Error; State Regulators may Remain Confused and Have Taken Enforcement ActionMarch 4th, 2009
By Wes Siegner – In April 2005, FDA published guidance for industry on dietary supplement labeling, “A Dietary Supplement Labeling Guide.” Chapter II of this guidance contains FDA’s views on how to fulfill the statement of identity requirement for dietary supplements contained in 21 C.F.R. § …
- Good News on FDA’s Phantom “Domestic Address” Requirement for OTC Drugs and Dietary Supplements; In a Tough Economy, Industry Could Save $84M – or More – by Doing NothingMarch 4th, 2009
By Cassandra A. Soltis & Wes Siegner – Previously we have commented on FDA’s draft guidance originally issued on January 2, 2008 and recently reissued again in draft form on December 11, 2008 (here and here). Both draft guidance documents assert that, in the Dietary …
- A Pig is a Pig Even if it Has Only Three Legs, is Laying Down or is FatiguedMarch 3rd, 2009
By Riëtte van Laack – The Eastern District Court of California enjoined California from enforcing California's Penal Code Section 599f against federally inspected swine slaughterhouses on the ground that section 599f is expressly preempted by the Federal Meat Inspection Act (“FMIA”). Section 599f prohibits a slaughterhouse …
- States Take Action to Limit Enviga Green Tea Beverage Weight Loss ClaimsMarch 3rd, 2009
By Cassandra A. Soltis – A settlement agreement reached between numerous state attorneys general and Coke, Nestle, and Beverage Partnership Worldwide makes clear that it is not just the Federal Trade Commission that is scrutinizing weight loss claims. The target of the attorneys general action …
- Stimulating Privacy: Changes to HIPAA in the Stimulus BillMarch 2nd, 2009
By Susan Matthees and Jeff Wasserstein – Although the stimulus bill that President Obama recently signed into law received significant attention for its economic implications, less noticed was Title XIII of the stimulus bill, entitled the "Health Information Technology for Economic and Clinical Health Act" or …
- Obama Pledges To Open Borders for Personal Importation of Prescription DrugsMarch 2nd, 2009
By Douglas B. Farquhar – More than nine years after passage of federal legislation that would permit individuals to legally import prescription drugs from Canada, the Obama Administration appears ready to open the door to importation. Prior administrations, including President Clinton’s, prevented individuals from legally …
- Actavis Sues FDA Over VYVANSE Exclusivity; Action Challenges FDA’s NCE Exclusivity PoliciesMarch 1st, 2009
By Kurt R. Karst – Actavis Elizabeth LLC (“Actavis”) has sued FDA after the Agency refused to accept the company’s ANDA for a generic version of the ADHD drug VYVANSE (lisdexamfetamine dimesylate) Capsules earlier this year. FDA’s Orange Book shows that VYVANSE is a Type …
- Obama Budget Part 2: Reducing Drug PricesMarch 1st, 2009
By Alan M. Kirschenbaum – Last week we reported on the Obama Administration’s 10-year budget proposal, focusing on the Department of Health and Human Services budget. As noted, the budget establishes a reserve fund of over $630 billion over 10 years to finance health care reform. …
- Yet Another Petition is Submitted to FDA Concerning the QI Act & 30-Month Stay Availability; Latest Petition Concerns CELLCEPTFebruary 27th, 2009
By Kurt R. Karst – Over the past few weeks, we have posted (here and here) on citizen petitions submitted to FDA requesting that the Agency address whether the 30-month stay provisions of the Hatch-Waxman Amendments apply to a pending ANDA for a generic version …
- Obama 10-Year Budget Blueprint Includes Initiatives For Medicare, Medicaid, FDAFebruary 26th, 2009
By Cassandra A. Soltis & Alan M. Kirschenbaum – Today the Obama Administration released a summary of its 10-year budget proposal entitled “A New Era of Responsibility – Renewing America’s Promise.” The document provides a high level outline of priorities – details reportedly will be released in April. …