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    Month: July 2012

    • FDA Divides Filing Criteria for PMAs into “Acceptance Criteria” and “Filing Criteria”July 31st, 2012

      By Jennifer D. Newberger – The Medical Device User Fee Amendments of 2012 ("MDUFA III") require FDA to “publish guidance outlining electronic copy of submissions ("e-Copy") and objective criteria for revised ‘refuse to accept/refuse to file’ checklists.”  On July 30, 2012, FDA issued a draft guidance …

    • PDUFA V Begins With Relatively Modest Changes to User Fee RatesJuly 31st, 2012

      By Kurt R. Karst –       In two Federal Register notices (here and here) scheduled for publication on August 1st, FDA will announce the Fiscal Year (“FY”) 2013 user fee rates pursuant to the fifth iteration of the Prescription Drug User Fee Act (“PDUFA”) and pursuant to …

    • DEA Controls Prostanozol and Methasterone As Schedule III Anabolic SteroidsJuly 30th, 2012

      By Karla L. Palmer & Larry K. Houck – The Drug Enforcement Administration (“DEA”) published a Final Rule on July 30th (77 Fed. Reg. 44,456 (July 30, 2012) placing prostanozol and methasterone into Schedule III of the federal Controlled Substances Act (“CSA”) as anabolic steroids.  DEA’s administrative scheduling of prostanozol and …

    • WSJ Article on Medical Foods Repeats Common Errors, but Illustrates Importance of Healthcare OptionsJuly 29th, 2012

       By Wes Siegner – The article “‘Medical Foods’ and Supplements for Brain Health Advance” that recently appeared in The Wall Street Journal provides important insights into a growing industry that is focused on offering a wider range of healthcare options.  However, the article contains common misconceptions …

    • DEA Leads First Nationwide Synthetic Drug Takedown in “Operation Log Jam”July 29th, 2012

      By Karla L. Palmer & Larry K. Houck – Drug Enforcement Administration (“DEA”) Administrator Michele M. Leonhart, accompanied by officials from Internal Revenue Service Criminal Investigations (Richard Weber), Immigration and Customs Office of Homeland Security (James Chaparro), and U.S. Postal Inspections, held a press conference yesterday announcing …

    • D.C. Circuit Decides Case Involving Exclusion of Former Purdue ExecutivesJuly 27th, 2012

      By John R. Fleder – On July 27, 2012, the United States Court of Appeals for the D.C. Circuit issued its long-awaited ruling in Friedman v. Sebelius, No. 11-5028.  The case involves a challenge to a decision by the Secretary of Health and Human Services ("HHS") …

    • Cytori Files Unusual Request for Court Review of FDA Decision Not to Permit Marketing of Medical DeviceJuly 27th, 2012

      By Douglas B. Farquhar –  In a rare request for a court to review FDA’s failure to clear a medical device for market distribution, arguments have been finalized, briefs have been filed, and oral argument has been scheduled for September 21, 2012. The case, filed in the U.S. …

    • Designer Anabolic Steroid Control Act of 2012 Introduced; Would Bulk Up Federal Anabolic Steroid ControlsJuly 26th, 2012

      By Larry K. Houck –  Senators Orrin Hatch (R-UT) and Sheldon Whitehorse (D-RI) introduced legislation on July 25, 2012, that would amend the definition of “anabolic steroid” under the Federal Controlled Substances Act (“CSA”) and expressly add twenty-seven additional anabolic steroids to schedule III.  The …

    • The Regenerative Sciences – FDA Court Struggle Ends . . . For NowJuly 25th, 2012

      By William T. Koustas – We have been following the litigation between Regenerative Sciences, LLC (“Regenerative”) and FDA for over two years (see here, here, here, here, and here.  On Monday, the United State District Court for the District of Columbia ruled in favor of FDA …

    • STOPP Act Would Establish New Requirements for Tamper-Resistant DrugsJuly 24th, 2012

      By Kurt R. Karst –       Last week, Representative William Keating (D-MA) announced the introduction of new legislation – the Stop Tampering of Prescription Pills Act of 2012, or STOPP Act (H.R. 6160) – that is intended to direct companies “to invest in research and production to …

    • FDA Issues Draft Guidance Expanding Pre-IDE to Pre-Submission ProgramJuly 23rd, 2012

      By Jennifer D. Newberger – The pre-Investigational Device Exemption ("IDE") program, established in 1995, was originally intended as a way for sponsors to obtain FDA feedback on future IDE applications.  Over time, the program expanded to include feedback on other submissions, such as premarket approval ("PMA") applications, …

    • March Away From BPA ContinuesJuly 20th, 2012

      By Ricardo Carvajal – FDA published a Federal Register notice announcing the filing of Rep. Edward J. Markey’s food additive petition asking the agency to amend its regulations “to no longer provide for the use of Bisphenol A (BPA)-based epoxy resins as coatings in packaging for …

    • Lack of Regulatory Guidance Fatal to Some, But Not All Claims in AMP False Claims Act CaseJuly 19th, 2012

      By JP Ellison –  In a July 3, 2012 memorandum opinion out of the Eastern District of Pennsylvania, the court granted in part and denied in part the defendants’ motion to dismiss the plaintiff’s claims for failure to state a claim.  The case, United States of …

    • Debarred By FDA! For What? For How Long? Really?July 17th, 2012

      By Benjamin K. Wolf* & John R. Fleder – Dr. Glen R. Justice, a 67 year old oncologist and hematologist, pleaded guilty to defrauding government, public and private insurers out of at least $400,000.  The government alleged that Dr. Justice billed for treatments either not given …

    • FTC v. POM Wonderful: the Battle ContinuesJuly 17th, 2012

      By Riëtte van Laack – As we anticipated, both the FTC Staff and POM Wonderful appealed the May 17, 2012 Initial Decision by the FTC’s Administrative Law Judge (ALJ).  Among other things, the FTC Staff appealed the ALJ’s conclusion that substantiation of disease efficacy claims does …

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