By Kurt R. Karst – The National Organization for Rare Disorders (“NORD”) announced the submission of a Citizen Petition to FDA requesting “that a documented policy be established regarding the review of potential treatments for people with rare diseases.” The petition comes on the heels of …
By Kurt R. Karst – Last week, FDA issued its highly anticipated Proposed PDUFA V Reauthorization Performance Goals and Procedures for Fiscal Years 2013 through 2017, which were hammered out between FDA and industry after long negotiations. The proposal includes several new provisions compared to the …
By Kurt R. Karst – A recent Citizen Petition submitted on behalf of Abbott Laboratories (“Abbott”) calls into question FDA’s authority for granting Therapeutic Equivalence (“TE”) ratings (i.e., “A” ratings) for drug products approved pursuant to FDC Act § 505(b)(2). Specifically, Abbott’s petition requests that FDA …
By Kurt R. Karst – In what appears to be the first instance in which a court has considered the U.S. Supreme Court’s decision in PLIVA, Inc. v. Mensing in the context of a preemption defense in a state tort-law failure-to-warn case, Nevada State Court Judge Jerry …
By Kurt R. Karst – In a Report to Congress issued earlier this year and recently made public, FDA’s Rare Disease Group (“RDG”) and Neglected Tropical Disease Group (“NTDG”) report on their findings and recommendations to improve the current regulatory/scientific armamentarium to facilitate the development of …
By Kurt R. Karst – On August 31, 2011, the Federal Trade Commission (“FTC”) announced the issuance of its final report, titled “Authorized Generic Drugs – Short-Term Effects and Long-Term Impact,” which has been in the works for years since it was requested in 2005 by …
By Anne Marie Murphy – This week FDA announced the publication of a draft guidance titled, “Oversight of Clinical Investigations: A Risk Based Approach to Monitoring.” This is the first time since 1988 that the agency issued a specific guidance document on how a study sponsor …
By Kurt R. Karst – On August 29, 2011, Public Citizen announced that it submitted a citizen petition to FDA requesting that the Agency amend its regulations to permit ANDA sponsors to revise their labeling through the Changes Being Effected (“CBE”) and Prior Approval Supplement (“PAS”) …
By Kurt R. Karst – Recently we reported on the “other battle” going on concerning patents listed in the Orange Book for The Medicines Company’s (“MDCO’s”) ANGIOMAX (bivalirudin) Injection. With patent reform reportedly high on President Obama’s agenda, and with the fast approaching September 6th return of …
By Kurt R. Karst – The court battle over the “new drug” status of Cody Laboratories, Inc.’s and Lannett Co., Inc.’s (collectively “Cody/Lannett’s”) Morphine Sulfate Oral Solution 20mg/mL drug product has taken a new turn. FDA’s Motion to Dismiss the case on mootness grounds has been …
By Kurt R. Karst – With all of the hullabaloo that has been going on in court and on Capitol Hill in the continuing battle over a Patent Term Extension (“PTE”) for U.S. Patent No. 5,196,404 (“the ‘404 Patent”) covering The Medicines Company’s (“MDCO’s”) ANGIOMAX (bivalirudin) …
By Kurt R. Karst – FDA recently denied (here and here) two citizen petitions (here and here) submitted on behalf of ECR Pharmaceuticals (“ECR”) and Laser Pharmaceuticals, LLC (“Laser”) requesting that FDA, among other things, reconsider its determinations that certain marketed unapproved drug products containing brompheniramine …
By Kurt R. Karst – The latest battleground over the period of exclusivity that should apply to biological products is the Trans-Pacific Partnership (“TPP”) trade agreement. As you might recall, earlier this year there was quite a hubbub over whether the 12-year reference product exclusivity period provided …
The American Conference Institute will be holding its 12th annual “Maximizing Pharmaceutical Patent Life Cycles” conference in New York City from October 3-5, 2011. A copy of the conference program is available here. Hyman, Phelps & McNamara, P.C.’s Kurt R. Karst will be presenting at …
By Cassandra A. Soltis & Anne Marie Murphy – The Department of Health and Human Services, Office of the Secretary, along with the Office of Science and Technology Policy, has issued an advance notice of proposed rulemaking (“ANPRM”) requesting comments on how to update current regulations on …
