By Kurt R. Karst – Each year around this time, some of us at our firm participate in a version of The Price Is Right Showcase Showdown in which folks “bid” on what they think the PDUFA application user fee rate will be set at for …
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Drug Development
- PDUFA IV User Fees End With a Bang, Not a Whimper! Application Fee Increases by a Whopping 19.4% (or Almost $300K)July 31st, 2011
- Maine Repeals Laws Requiring Disclosures of Marketing Costs, Drug Prices, and Clinical TrialsJuly 13th, 2011
By Nisha P. Shah – Under a bill titled, “An Act to Make Certain Prescription Drug Disclosure Laws Consistent with Federal Law,” the State of Maine repealed three laws related to the reporting of marketing costs, price reporting, and the disclosure of clinical trials by manufacturers …
- Priority Review Vouchers – Not Much Bang for the BuckJuly 11th, 2011
By Kurt R. Karst – A recent article in The RPM Report concerning the apparent fate of the only Priority Review Voucher (“PRV”) issued to date by FDA caught our attention. Kudos to The RPM Report team, which took note of some statements made during a …
- Will the Dog Days of Summer Offer a Reprieve to FDA and the Regulated Industry (and Your Bleary-Eyed Bloggers)? DoubtfulJuly 6th, 2011
By Kurt R. Karst – Over the Independence Day holiday, in between the family BBQ and fireworks, we had a few minutes to reflect on what a hectic month June was for FDA and the regulated industry. There were the decisions handed down by the U.S. …
- Freedom and Unity to Use IMS Prescribing Data in VermontJune 24th, 2011
By Ben Wolf* and Jeff Wasserstein – Justice Kennedy delivered the opinion of the Supreme Court in today’s 6-3 decision in Sorrell v. IMS Healthcare Inc. (Docket No. 10-779). This decision strikes down a Vermont law prohibiting the sale, disclosure, and use of pharmacy records that reveal …
- HP&M Director Named to ACTION Board of AdvisorsJune 15th, 2011
Hyman, Phelps & McNamara, P.C.’s David B. Clissold has been named to the Board of Advisors of Analgesic Clinical Trial Innovations, Opportunities, and Networks (“ACTION”). ACTION is a public-private partnership aligned with FDA’s recently launched Initiative for the Advancement of Regulatory Science. ACTION is designed …
- FDA Issues Final 505(q) Citizen Petition Guidance, Says Certification/Verification Statement Accuracy is ParamountJune 9th, 2011
By Kurt R. Karst – Earlier this week, FDA announced the availability of a final guidance document, titled “Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act,” explaining the Agency’s interpretation of this statutory provision …
- Kansas Federal Grand Jury Indicts Physician and Research Coordinator for Falsifying Clinical trial Study DataJune 8th, 2011
By Peter M. Jaensch – In what a federal grand jury charges was a several-months-long effort in 2010 to maintain their job security, a clinical trial investigator and clinical trial coordinator in Kansas allegedly falsified clinical drug trial study data in submissions to the Food and …
- GAO Report Finds BPCA and PREA to be Ongoing Successes, But Says that FDA Needs to Improve Tracking of Products Studied for Pediatric UsesJune 6th, 2011
By Nisha P. Shah & Kurt R. Karst – The U.S. Government Accountability Office (“GAO”) recently issued a report required by the FDA Amendments Act of 2007 (“FDAAA”) concerning the effects of the Pediatric Research Equity Act (“PREA”) (FDC Act § 505B) and the Best Pharmaceuticals …
- HP&M Director to Moderate at FDLI REMS ConferenceMay 11th, 2011
Hyman, Phelps & McNamara, P.C., Director Josephine M. Torrente will be moderating a session at the Food and Drug Law Institute’s (“FDLI’s”) upcoming 1-day conference on Risk Evaluation and Mitigation Strategies (“REMS”), which were created under the 2007 FDA Amendments Act. The FDLI conference, for …
- D.C. Circuit is Asked to Review Two DESI “New Drug” DecisionsMay 2nd, 2011
By Kurt R. Karst – FDA’s recent move to remove from the market hundreds of unapproved cough, cold, and allergy drug products has spawned two new lawsuits that might very well be one of the last hurrahs for court challenges to FDA Drug Efficacy Study Implementation-related …
- Analyst Report Suggests Recent Uptick in NDA/BLA Refuse-to-File Letters Signals Changes at FDAApril 26th, 2011
By Kurt R. Karst – A recent report from Leerink Swann LLC analyst Howard Liang, Ph.D. suggests that what appears to be a recent increase in the number of Refuse-to-File (“RTF”) letters issued by FDA to NDA and BLA sponsors – some of which are large, …
- “Responding to America’s Prescription Drug Abuse Crisis”: Administration’s New Action Plan Includes Changes to the CSAApril 21st, 2011
By John A. Gilbert, Jr. & Peter M. Jaensch – In a press conference at the National Press Club on April 19, 2011, the Administration presented its action plan (“Plan”) to address concerns about the increase in prescription drug abuse. The Plan is entitled: “Epidemic: Responding to …
- FDA Releases Opioid Class-Wide REMSApril 21st, 2011
By William T. Koustas – On Tuesday, April 19, 2011, after years of debate and several public meetings, FDA released the final Risk Evaluation and Mitigation Strategy ("REMS") it will require for all extended-release opioid medications. The final REMS was issued as part of the White …
- Former FDAer Linda S. Carter Joins Hyman, Phelps & McNamara, P.C.April 18th, 2011
Hyman, Phelps & McNamara, P.C. is pleased to announce that Linda S. Carter will join the Firm as a Regulatory Scientist on April 19th. Linda, who will primarily assist HP&M’s drug development group, brings significant experience and expertise in shaping regulatory policies, particularly Comparative Effectiveness …