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Focus on Regulation

Tag Archives: pharmaceutical

The Crackdown Continues:  FDA Takes Action Against Company And Its Autologous Stem Cell Product, Alleging Significant Safety Concerns

Yesterday, FDA published a January 3, 2018 Warning Letter issued to American CryoStem for marketing Atcell—an adipose tissue derived stem cell product—without FDA approval and for several drug current Good Manufacturing Practice (GMP) violations observed during FDA’s  July 2017 inspection of American CryoStem’s New Jersey facility.  In a related press release, the agency cited the

Continuing Coverage of FDA’s Crackdown on Stem Cell Clinics: Florida Clinic Cited for Unapproved Marketing and Inadequate Sterility Assurance

On the same day that FDA’s Commissioner, Dr. Scott Gottlieb, announced new policy initiatives regarding stem cell therapies and regenerative medicine, FDA announced stepped up enforcement in this area and posted a warning letter issued to U.S. Stem Cell Clinic located in Sunrise, FL.  FDA issued the warning letter following an inspection beginning in April

FDA Seizes Stem Cell Therapy—A First of Many?

On August 25, 2017, U.S. Marshals Service, at the request of FDA, seized five vials of ACAM20000—a smallpox vaccine containing live vaccinia virus (cow pox), which is reserved for people at high risk of contracting the disease—that were discovered during an FDA inspection at StemImmune Inc., a San Diego, California company that purports to specialize

FDA, EU Regulators Agree to Share Unredacted Inspection Reports and Other Confidential Information

The U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the European Commission – DG Sante (DG Sante), signed a new confidentiality commitment which expands the scope of the current confidentiality arrangements that apply to the cooperative law enforcement activities conducted by the regulators.  The new confidentiality commitment allows the regulators to share

HHS Overhauls the Common Rule to Enhance Protection for Human Subjects in Research

On January 18, 2017, as one of the last actions of the outgoing Obama administration, the U.S. Department of Health and Human Services (HHS) and fifteen other federal agencies (the “Agencies”) issued a final rule overhauling the regulations (82 Fed. Reg. 7149, Jan. 19, 2017) intended to safeguard individuals participating in research, often referred to

Scottish government to reform approval process for new end-of-life and orphan medicines

The Scottish government has announced plans to implement the 28 recommendations proposed in an independent review of access to new end-of-life, orphan and ultra-orphan medicines by patients in Scotland, published in a report on 14 December 2016. The recommendations aim to further improve the process by which these types of medicines, in particular ultra-orphan products,

European Court invalidates transfer of clinical data from the EU to the U.S through the Safe Harbor Framework

The Court of Justice of the European Union declares invalid the European Commission’s Safe Harbor Decision and its implications on the transfer of clinical data to the U.S On 6 October 2015, the Court of Justice of the European Union (“CJEU”) ruled that the European Commission Decision on the adequacy of the EU-U.S Safe Harbor

Antitrust in China’s pharma sector – Bengbu action following big-bang reform

On 26 August 2015, the National Development and Reform Commission (NDRC) made public its first antitrust enforcement decision in the pharmaceutical sector since launching the drug pricing reform earlier this year. Although the target of this enforcement action was a local government entity, pharmaceutical companies should expect continued antitrust intervention in parallel with the implementation

European Medicines Agency Adopts Policy on Publication of Clinical Data for Medicinal Products

On 2 October 2014, the European Medicines Agency (EMA) adopted its long awaited policy on the publication of clinical data for medicinal products (the Policy). Under the Policy, the EMA will proactively publish on its website clinical data submitted as part of an application for marketing authorization for medicinal products through the centralized procedure. The clinical data shall be published following completion of the decision-making process.

Federal Circuit Revives Certain Sham Petitioning Antitrust Counterclaims in Tyco-Mutual ANDA Litigation

In a split decision, the U.S. Court of Appeals for the Federal Circuit affirmed summary judgment on two antitrust counterclaims brought by Mutual Pharmaceutical Co. (“Mutual”) against Tyco Healthcare Group (“Tyco”), while vacating summary judgment on two others.  Although the ruling is just the latest in a long line of cases analyzing sham petitioning issues

FDA Issues Two Proposed Guidance Documents For Laboratory Developed Tests

On July 31, 2014, FDA provided Congress advance copies of two proposed guidance documents regarding Laboratory Developed Tests (LDTs), which the Agency had planned to issue 60 days later.  The first is titled FDA Notification and Medical Device Reporting for Laboratory Developed Tests; the second is Framework for Regulatory Oversight of Laboratory Developed Tests.  (A

FDA Issues New Draft Guidance on Identification of Suspect Products and Notification

On June 11, 2014, the FDA announced the availability of a draft guidance entitled “Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification.” The draft guidance clarifies for trading partners certain new requirements in the Federal Food, Drug, and Cosmetic Act, as amended by the Drug Supply Chain Security Act (DSCSA). The

FTC finalizes rule extending reporting requirements for pharmaceutical patent transfers

On 6 November 2013 the Federal Trade Commission (FTC) announced final changes to certain Hart-Scott-Rodino (HSR) rules regarding acquisitions of exclusive patent rights in the pharmaceutical industry. The revised rules, which apply only to transfers of pharmaceutical patent rights, will increase the number of licensing arrangements in the pharmaceutical industry that will be subject to the

FTC Commissioner Offers Post-Actavis Analysis & Predictions

In a recent speech, FTC Commissioner Joshua Wright offered extensive commentary on the Supreme Court’s recent ruling on pharmaceutical patent settlements, FTC v. Actavis, predicting that the ruling will prove to be a “boon” for economic litigation consulting firms.  According to Wright, this is because the Court’s rule of reason framework “appears to invite significantly

FTC Closes Seven-Year Adderall XR Pay-for-Delay Investigation

Last week the FTC announced that it was closing its investigation of patent settlement agreements between Shire Laboratories, Barr Pharmaceuticals, and Impax Laboratories related to Adderall XR without taking action.  Under the terms of the Shire-Barr agreement, Barr agreed not to offer a generic version of Adderall XR until April 2009 and Shire appointed Barr

Shire Wins Dismissal of Adderall XR Monopolization Case

A court in the Southern District of New York recently dismissed a monopolization claim brought by Louisiana Wholesale Drug Co. alleging that Shire violated Sherman Act §2 when it allegedly breached license and supply agreements with two generic firms related to its drug, Adderall XR.  The license and supply agreements were the result of the

FTC Issues Annual Overview of Pharmaceutical Patent Settlements

According to a report issued by the FTC yesterday, a record number of settlements between brand name and generic drug manufacturers reported to the Commission last year potentially constituted so-called “pay-for-delay” agreements. Defined by the FTC as a settlement involving both compensation to the generic as well as limitations on the generic’s ability to market

EU ruling on when dealings with patent and other regulatory authorities can infringe competition rules

On 6 December 2012, the Court of Justice of the European Union (“CJEU”) handed down the final chapter in the long-running AstraZeneca case (Case C-457/10P, AstraZeneca v European Commission). Whilst the CJEU refrained from establishing a detailed test for when conduct before a patent office can constitute an abuse of a dominant position, it confirmed that misuse of regulatory procedures

Updates from FDLI’s Advertising & Promotion Conference and the Pharmaceutical & Regulatory Compliance Congress

Recently, industry leaders, members of the FDA bar, and government officials convened at the Food & Drug Law Institute’s (FDLI’s) Advertising & Promotion Conference and the Pharmaceutical & Regulatory Compliance Congress. Topics included policy updates and enforcement priorities from FDA’s centers, Office of Inspector General (OIG) and Department of Justice (DOJ) current and future enforcement

Recent Janssen/J&J Risperdal State Settlement Restricts Certain Promotional Activities for Atypical Antipsychotics

On August 30, 2012, Janssen Pharmaceuticals, Inc. (“Janssen”) and its parent company, Johnson & Johnson, agreed to pay $181 million to 37 states and the District of Columbia to settle allegations that the marketing and advertising of its atypical antipsychotic products (Risperdal, Risperdal Consta, Risperdal M-Tab, and Invega) violated state consumer protection laws.  The settlement imposes