All posts by Kathleen Peterson

HHS OIG Hands Out 2015 Work Plan For Halloween

On Friday October 31, 2014, the U.S. Department of Health & Human Services (HHS) Office of Inspector General (OIG) released its annual “Work Plan” for fiscal year 2015.  The Work Plan is a compilation of the OIG’s plans for new and ongoing reviews and activities (including audits, evaluations, and certain […]

PhRMA Challenges HRSA Interpretative Rule on Orphan Drugs in the 340B Drug Discount Program

On October 9, 2014, the Pharmaceutical Research & Manufacturers of America (“PhRMA”) filed a lawsuit seeking to enjoin the Health Resources Services Administration (“HRSA”) from implementing its July 23, 2014 “Interpretive Rule” regarding orphan drugs in the 340B Drug Discount Program (the “2014 Interpretive Rule”).  PhRMA’s lawsuit alleges that the 2014 […]

9th Circuit Upholds Alameda County Manufacturer-Funded Drug Disposal Ordinance

On September 30, 2014, the U.S. Court of Appeals for the 9th Circuit unanimously upheld a lower court’s finding that a California county ordinance requiring prescription drug manufacturers to operate and finance certain drug disposal operations was constitutional.  The plaintiffs-appellants in Pharm. Research & Mfrs. of Am v. County of Alameda (9th Cir., […]

FDA Releases Five New Compounding Pharmacy Policy Documents

Yesterday, the U.S. Food and Drug Administration (FDA) released five documents outlining the FDA’s current policies regarding compounded drug products for human use.  All of the documents are available through the FDA’s website.  Tuesday’s issuances were part of the FDA’s continued implementation of the Drug Quality and Security Act (DQSA), […]

HRSA Stands By Its Interpretation of 340B Drug Discount Program Orphan Drug Availability, Despite Court Decision Vacating Regulation

The U.S. Department of Health & Human Services (HHS) Health Resources and Services Administration (HRSA) published today a statement responding to the recent court decision vacating the 340B Drug Discount Program Orphan Drug Rule.  As we previously reported, the D.C. District Court permanently enjoined HRSA from implementing its July 23, 2013 […]

340B Drug Discount Program Orphan Drug Rule Vacated:  ACA “New” Covered Entity Types No Longer Authorized to Purchase Orphan Drugs Under the 340B Program, Regardless of Indications

[UPDATE 6/18/2014: HRSA has issued a statement that it continues to stand by its interpretation of ACA permitting new covered entities to purchase orphan drugs under the 340B program for non-orphan use. See our more recent post for updated information.] The D.C. District Court permanently enjoined the U.S. Department of Health & Human […]

CMS to Congress: “We Do Not Plan to Finalize” Certain Controversial Medicare Part D Proposals – All “Protected Classes” Will Remain Protected. For Now.

Yesterday, the Centers for Medicare & Medicaid Services (“CMS”) Administrator Marilyn Tavenner responded to several Congressional concerns regarding CMS’ recent proposed rule on the Medicare Part D outpatient prescription drug benefit.  We previously reported on that proposed rule here.  In a Letter to Representative Sander Levin, Ranking Member of the House […]