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 …
By Anne Marie Murphy – As we have reported previously, Title VIII of the Food and Drug Administration Amendments Act of 2007 (“FDAAA”) amended the Public Health Service Act (“PHS Act”) by adding new section 402(j), 42 U.S.C. § 282(j), which greatly expands the types …
By Carrie S. Martin & Anne Marie Murphy – As we have previously reported, the Consumer Product Safety Improvement Act of 2008 (“CPSIA”) makes a number of changes to the laws enforced by the Consumer Product Safety Commission (“CPSC”). Among those changes are new limits on …
By Alan M. Kirschenbaum – Today’s Federal Register announces FDA’s issuance of a final “Guidance for Industry on Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical …
Kurt R. Karst of Hyman, Phelps & McNamara, P.C. (and co-chief blogger of FDALawBlog.net) will be speaking at two upcoming conferences on various Hatch-Waxman Act product lifecycle management issues. The first conference is the Center for Business Intelligence’s Premier Bio/Pharmaceutical Summit on Legal & Regulatory …
By Kurt R. Karst – Last week, ViroPharma Inc. announced that the company filed a complaint in the U.S. District Court for the District of Columbia alleging that FDA has “wrongfully withheld agency records requested by [ViroPharma] by failing to comply with the statutory time limit for …
