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The Brookings Institution Issues Report on National Medical Device Surveillance System
…initiative, a multi-stakeholder Planning Board was created with the purpose of “envisioning an MDS with the capability of accurately and systematically evaluating potential medical device safety signals in near real-time,…
Tag-Team Enforcement: After Years of FTC Proceedings, Rhode Island Businessman Pleads Guilty to FDC Act and Tax Violations
…was Daniel Chapter One, a company owned by Mr. Feijo and his wife Patricia. Daniel Chapter One was said to market herbal formulations and shark cartilage for the prevention, treatment and…
FTC Alleges Companies Were Asleep At the Wheel When They Failed to Report Settlement Agreements on AMBIEN CR; Commission Uses the Opportunity to Provide Industry Guidance – And a Warning
…the ANDA was submitted.’ MMA § 1112(a)(2)(B). That is the case notwithstanding that the stipulation was filed pursuant to Federal Rule of Civil Procedure 41(a) to secure a dismissal. ….
PhRMA’s Complaint Against Enforcement of California Drug Pricing Transparency Bill SB 17 Dismissed
…California Office of Statewide Health Planning and Development (OSHPD) website here. Briefly, PhRMA’s lawsuit challenged SB 17 on three distinct constitutional grounds. First, PhRMA alleged that SB 17 violates the…
Fourth Circuit Finds Maryland Price Gouging Law Unconstitutional
…civil remedies, including injunctive relief, monetary relief, and civil penalties, for violations of the law. As we also previously reported, in July 2017 the Association for Accessible Medicines (“AAM”) filed…
HRSA Issues Final Rule Regarding the 340B Penny Pricing Policy and Manufacturer CMP
…H.R. 5982, 114th Cong. (2016), which would amend the Congressional Review Act to allow Congress, by joint resolution, to reject a group of regulations submitted by federal agencies for congressional…
Price Limits, Affordability Boards, Penalties, Oh My: Minnesota Enacts Sweeping Drug Pricing Reforms
…request an appeal within 30 days of that decision, but note that it is the Board who makes the initial decision, hears the appeal, and renders the appeal decision. The…
Court Denies DEA Injunction to Suspend Practitioner’s Registration
…prescriptions to be valid, they must “be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” Judge Jackson cited examples…
The Congress and Its Camel – the Expansion of User Fees
…passed the Prescription Drug User Fee Act (“PDUFA”) establishing user fees for the review of “human drug applications,” the proverbial camel’s nose came under the tent. Although it can be…
Reps. Waxman and Allen and Sen. Kennedy Will Introduce Bill to Modernize the OTC Drug System
Yesterday, Representatives Henry Waxman (D-CA) and Tom Allen (D-ME) and Senator Ted Kennedy (D-MA) announced plans to introduce the Non-Prescription Drug Modernization Act of 2007 (“NDMA”). The bill comes in…
First Circuit Decision Signals Hurdles for Whistleblowers in Off-Label Promotion Cases
We have seen a rash of cases brought by the government and private “whistleblowers” alleging that companies have violated the Federal False Claims Act (“FCA”) by promoting the sales of…
Kevin Trudeau Finally Gets a Partial Victory against the FTC
…criminal contempt sanction, without providing certain constitutional safeguards that apply in criminal cases. The Court also found the infomercial ban to be improper because the ban was to last for…
OIG Calls for Increased FDA Food Inspections and Expanded Penalties
By Ricardo Carvajal – The Office of Inspector General (“OIG”) of the U.S. Department of Health and Human Services released a report that finds fault with FDA’s inspection activities for food…
New Combat Meth Act Increases Retailer Self Certification
…chemicals that can be used for illicit production of methamphetamine) to submit to the Attorney General an additional self-certification prior to selling at retail any SLCP. This “enhanced” certification requires…
Citing Imminent Hazard to Public Safety, DEA Temporarily Places Synthetic Cannabinoids Into Schedule I
…2011, the synthetic cannabinoids known as JWH-018, JWH-073, JWH-200, CP-47,497 and cannabicyclohexanol are subject to the Schedule I regulatory controls and administrative, civil and criminal sanctions imposed by the CSA…