The Drug Enforcement Administration’s (“DEA”) final rule allowing individual practitioners to issue multiple Schedule II prescriptions to individual patients to be filled sequentially went into effect on December 19, 2007. The rule will allow practitioners to prescribe up to a 90-day supply of a Schedule …
The Drug Enforcement Administration (“DEA”) recently issued an advisory announcing that as of January 1, 2008, manufacturers of methadone HCl 40 mg tablets have voluntarily agreed to limit distribution due to the reported increase of adverse events related to methadone. This raises new issues for …
We previously reported that two pharmacy associations were challenging the implementation of a rule promulgated by the Centers for Medicare & Medicaid Services (“CMS”) setting forth how to calculate the Average Manufacturer Price (“AMP”), the new, and importantly lower, benchmark for pharmaceutical reimbursement by Medicaid. …
Department of Defense (“DoD”) authorization bills currently pending in Congress (both H.R. 1585 and S. 1547) contain authority for a new, mandatory TRICARE retail pharmacy rebate program. TRICARE is the military’s health care program serving active duty service members, retirees, their families, survivors and certain …
On November 2, 2007, FDA published an Advance Notice of Proposed Rulemaking (“ANPR”) to revise nutrition labeling requirements for foods and dietary supplements. FDA’s ANPR commences perhaps the most sweeping food labeling modification effort since 1993, when FDA issued the nutrition labeling rules mandated by …
Earlier today, FDA issued a Federal Register notice announcing the Fiscal Year 2008 user fee rate for advisory review of Direct-to-Consumer (“DTC”) Television advertisements for prescription drug and biological products. The advisory review fee for FY2008 will be $41,390 for each proposed television advertisement voluntarily submitted …
Late last week, a yet-to-be released FDA draft guidance on “Good Reprint Practices” was made public by Rep. Henry Waxman (D-CA). Waxman, on behalf of the Committee on Oversight and Government Reform, issued a letter to FDA strongly urging it to refrain from finalizing and …
On Nov. 27, 2007, FDA published a proposed rule to restrict the use of nutrient content claims for the omega-3-fatty acids, alpha-linolenic acid (ALA), docosahexaenoic acid (DHA), and eicosapentaenoic acid (EPA). The Agency proposes to prohibit notified nutrient content claims for EPA and DHA and …
We previously reported that the Supreme Court had agreed to hear the PMA device preemption case Riegel v. Medtronic, Inc. The status of the case was in question earlier this fall because of an untimely motion to substitute the correct party (following the death of …
For the first time in over a decade, the United States Sentencing Commission (the “Commission”) is considering amending the Sentencing Guidelines that are applied to individuals and organizations convicted of criminal violations of the Federal Food, Drug, and Cosmetic Act (“FDCA”). See 72 Fed. Reg. …
