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DEA Updates Special Surveillance List of Precursor Chemicals and Equipment
…cathinones. Id. at 73,045. DEA noted that the Special Surveillance List informs about the potential illegal uses of the listed chemicals and other items. It reminds that civil penalties of…
Making the House FDA Reform Act of 2012 PAYGO Compliant – Are Expedited 505(q) Citizen Petition Responses the Answer?
…citizen petition process from being used to delay approval of ANDAs and 505(b)(2) applications. FDC Act § 505(q) provides that FDA shall not delay approval of a pending ANDA or…
FDA Misdemeanor Cases—Not Always A Sure Win for the Government
…misdemeanor. The other lesson from the outcome of this case is that it is almost never a good idea to voluntarily speak with government criminal investigators without legal counsel. As…
Supreme Court to Regulatory Agencies: Due Process Requires “Fair Notice” of Agency Interpretations
…an approval might raise these same constitutional concerns. Certainly, civil or criminal penalties, injunctions, or forfeiture actions would continue to be subject to the fair warning requirement. We are confident…
KV Takes a Hit With the Dismissal of Its Case Against FDA Over Compounded 17P
…. . . .” KV has also sued state Medicaid agencies in Illinois, Georgia, and South Carolina to cover MAKENA. In early August, KV won the Georgia case (see here)….
FTC Settlement with Medifast: Weight Loss and Maintenance Claims Must be Supported by One (Not Two) Well-controlled Study
…well-controlled clinical study of a “low calorie meal replacement program . . . designed to lower the user’s total caloric intake” that follows “acceptable designs and protocols” or a protocol…
DEA Proposes Controlling Lorcaserin in Schedule IV
…there is no actual abuse data. In these cases, the agencies review the results of clinical studies to use as a barometer of the potential that drug abusers will seek…
HHS Finalizes HIPAA/HITECH Rule: Dramatic Revisions to Marketing Practices and Research Authorizations
…could be used for a clinical study as well as for specimen collection for a central repository. Currently, compound authorizations are prohibited, which increases the burden on clinical trial sites…
Rebel Without a Cause: Sun Sues FDA Over 180-Day Exclusivity for Generic ZOMETA
…a Notice of Dismissal stating: “Pursuant to Rule 41(a)(1)(A)(i) of the Federal Rules of Civil Procedure, Plaintiffs Sun Pharma Global FZE, Caraco Pharmaceutical Laboratories, Ltd., and Sun Pharmaceuticals Industries, Ltd.,…
DC Circuit Reinstates KV Lawsuit Over MAKENA and Compounded 17p in Light of Cook Decision and DQSA
…waiting with bated breath for the U.S. Court of Appeals for the District of Columbia Circuit to rule on K-V Pharmaceutical Company’s (“KV’s”) appeal of a September 2012 decision from…
CDRH Issues Joint FDA/FTC Promotion and Advertising Untitled “Email” to On-line Distributors; Uses Unprecedented Approach to Warn of Possible Criminal Prosecution
By Carmelina G. Allis – On February 28, 2013, FDA’s Center for Devices and Radiological Health (“CDRH”) issued what appears to be an unprecedented joint FDA/Federal Trade Commission “untitled letter”…
FTC Loses Again; Court of Appeals Affirms Lower Court’s Determination that Garden of Life’s Expert Opinion Constitutes Competent and Reliable Evidence
…the relevant area” means experts in medicine or pharmacology in general rather than specialists in the given medical subspecialty was reasonable. Although the Court affirmed the lower court’s denial of…
Is the Malfunction MDR Reporting Requirement Unconstitutional?
…context, the terms “remote” or “not remote” are probability estimates that, unless applied correctly, can mean the difference between not being required to report and committing a civil and criminal…
Non-Designated Uses of Orphan Drugs – To 340B or Not to 340B?
…and will provide you with updates. The case is Pharmaceutical Research and Manufacturers of America v. US Department of Health and Human Services, et al., Civil Action No. 1:13-cv-01501 (D.D.C.)….
Jensen Farms Sues Auditor PrimusLabs
By Riëtte van Laack – Jensen Farms, (the Jensens), the growers facing criminal charges related to the deadly 2011 listeria outbreak linked to their cantaloupes, are suing Primus Group, Inc….