On May 15, 2007, the U.S Department of Agriculture (“USDA”) issued a proposed rule to amend the agency’s National Organic Program (“NOP”) regulations at 7 C.F.R. Part 205. The proposal, if finalized, would add 38 ingredients to the National List of Allowed and Prohibited Substances …
As pharmaceutical manufacturers all know by now, the Deficit Reduction Act changed the definition of the average manufacturer price reported to the Centers for Medicare & Medicaid Services for purposes of the Medicaid Rebate Program, requiring that customary prompt pay discounts to wholesalers are no …
The Centers for Medicare & Medicaid Services (“CMS”) proposed brand-specific Healthcare Common Procedural Coding System (“HCPCS”) code changes for intravenous immune globulin (“IVIG”) that may lead to enhanced reimbursement for the biologic. The HCPCS coding changes are effective July 1, 2007, and were announced in …
In the near future, one might see the following ad on Ebay or Craig’s List: "For Sale: One FDA Priority Review voucher. Mint condition. Entitles 505(b)(1) applicant to 6-month FDA review. Sponsor must pay additional user fee." In an effort to incentivize companies to invest in …
Earlier this week, the U.S. Senate passed S. 1082, the “Food and Drug Administration Revitalization Act” (“FDARA”) by a vote of 93-1 (Sen. Bernie Sanders (I-VT) was the lone “nay” vote). The bill is an omnibus FDA reform and user fee package that, among other …
Last week we reported on motions submitted by Mylan and Apotex requesting that the U.S. District Court for the District of Columbia reconsider its April 30, 2007 memorandum opinion concerning 180-day generic drug and pediatric exclusivity issues involving NORVASC (amlodipine besylate) Tablets and the availability …
On April 30, 2007, the District Court for the Southern District of Illinois issued its opinion in Connell v. Secretary of Health and Human Servs., No. 05-cv-4122-JPG, 2007 WL 1266575 (S.D. Ill. Apr. 30, 2007) concerning a final decision by the Secretary of the Department …
The Council for Entrepreneurial Development will hold a “MedTech” forum on June 6, 2007 in Research Triangle Park, NC to discuss FDA’s regulation of medical devices and device reimbursement under the Medicare program. HPM’s own Marc Shapiro will moderate the program. Jeff Gibbs and Kirk …
Yesterday, a former Federal Trade Commission (“FTC”) staffer recommended that drug companies follow a “moderate approach” in pursuing “reverse payments” — payments made by brand name companies to generic drug companies to persuade the generic companies to stay off the market for a particular drug. …
On April 25, 2007, the Senate Finance Committee released the results of a Committee inquiry into drug company grants to fund continuing education for medical providers. The Finance Committee report was two years in the making and addresses the Committee’s belief that the pharmaceutical industry …
FDA has come under fire from U.S. lawmakers and public interest groups for its handling of a spate of recent food contamination outbreaks concerning E. coli-contaminated bagged spinach, salmonella-contaminated peanut butter, and melamine-contaminated pet food and animal feed. Speaking at a recent congressional hearing, former …
It has been a hectic week for those of us following the various twists and turns involving generic versions of Pfizer’s high blood pressure drug NORVASC (amlodipine besylate) Tablets and the availability and applicability of both 180-day generic drug exclusivity and pediatric exclusivity with respect …
On May 2, 2007, FDA announced the availability of a report, titled “Critical Path Opportunities For Generic Drugs.” The report identifies several unanswered scientific questions that FDA believes impede the development of generic versions of commonly used brand name drugs, and is part of FDA’s …
As we previously reported, FDA has promised to accelerate its enforcement efforts against marketed unapproved drugs in 2007. Indeed, in the past month, FDA has announced two enforcement actions, and future actions are likely. In early April 2007, FDA announced that companies must stop manufacturing and …
Hyman, Phelps & McNamara, P.C. is very pleased to announce that Jeffrey K. Shapiro has joined the firm as a director. Prior to joining the firm, Mr. Shapiro was a partner at Hogan & Hartson. Mr. Shapiro’s practice focuses primarily on assisting medical device and …
