By Kurt R. Karst – Earlier this week, FDA announced that the Agency will reverse course and grant Amyotrophic Lateral Sclerosis (“ALS”) patients “compassionate use” access to IPLEX (mecasermin rinfabate [rDNA origin] injection). FDC Act § 561, which was added to the statute in 1997 …
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 …
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. …
By Cassandra A. Soltis & Wes Siegner – Previously we have commented on FDA’s draft guidance originally issued on January 2, 2008 and recently reissued again in draft form on December 11, 2008 (here and here). Both draft guidance documents assert that, in the Dietary …
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 …
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. …
By J.P. Ellison – Twenty-Seven Attorneys General have given FDA prior approval authority over Bayer’s Direct-to-Consumer (“DTC”) television and print advertising for its prescription oral contraceptive Yaz, and also required to company to run a $20 million corrective advertising campaign as part of a settlement agreements with …
By Bill T. Koustas – On February 9, 2009, FDA (or “the Agency”) announced it has invited the sponsors of opioid drug products to a private meeting in March in order to begin the process of developing Risk Evaluation and Mitigation Strategies (“REMS”) that will …
By Jamie K. Wolszon – On January 21, 2009, the California Supreme Court decided that it would not review a remarkable California appeals court decision that a brand-name drug manufacturer could be liable for an adverse event the plaintiff suffered as a result of taking …
By Michelle L. Butler – With the effective date for a number of requirements imposed by the Consumer Product Safety Improvement Act (“CPSIA”) quickly approaching (February 10, 2009), the Consumer Product Safety Commission engaged in a flurry of activities. We recently reported on the Commission’s decision …
By Ricardo Carvajal – FDA has approved the biological product ATryn, an anticoagulant derived from the milk of genetically engineered ("GE") goats. The approval follows on the heels of the agency’s issuance of long-awaited guidance on its regulatory approach to GE animals, which we discussed …
By Ricardo Carvajal & Susan J. Matthees – The FDA Globalization Act (“FDAGA”) of 2008 was “meant to stimulate discussion about how to provide adequate funding and authority for FDA to ensure safety” of products over which the agency has jurisdiction. When we commented on …
By Anne Marie Murphy – We previously reported on the Consumer Product Safety Improvement Act of 2008 (“CPSIA”), which makes sweeping changes to the laws enforced by the Consumer Product Safety Commission (“CPSC”). CPSIA Section 102(a), paragraph (1), amends the Consumer Product Safety Act (“CPSA”) to require …
By Jamie K. Wolszon – On January 22, Senators Herb Kohl (D-WI) and Charles Grassley (R-IA) introduced the Physician Payments Sunshine Act of 2009, which would require drug, biologic, medical device, and other medical supply manufacturers to disclose to the Secretary of Health and Human …
By Kurt R. Karst – Those following the subject of preemption of conflicting state laws have speculated for months whether the Obama Administration might undo the position FDA has advanced in Federal Register announcements and in court filings in which the Agency has generally staked …
