Earlier today, FDA Commissioner Scott Gottlieb, M.D., made publicly available for the first time FDA’s internal policy (MAPP 5014.1) for how drug manufacturing facilities are prioritized and scheduled for surveillance inspections. According to the press release, in 2017, approximately 5,063 drug establishments were subject to routine surveillance inspection; out of these approximately 5,063 eligible drug
Update (9/18/2018): Last week, as the U.S. House of Representatives was reconciling its spending bill for the Health and Human Services Department (HHS) with the amendment package passed by the U.S. Senate that is discussed below, House Republicans declined to adopt S.Amdt. 3964, which would have provided HHS with $1 million to issue rules requiring pharmaceutical companies to list prices
On July 18, FDA Commissioner Scott Gottlieb, M.D., announced the release of FDA’s Biosimilars Action Plan (BAP), saying it would help enable a path to competition for biologics from biosimilars, while preserving incentives for innovators to invest in further research. On July 19, FDA also published the guidance “Labeling for Biosimilar Products,” finalizing an April
This morning, FDA’s Center for Biologics Evaluation and Research (CBER) published six draft guidances relating to gene therapy, three of which cover products for specific disease categories (hemophilia, rare diseases, and retinal disorders), and three of which address manufacturing and clinical study design issues related to gene therapy: chemistry, manufacturing and control (CMC) information in
On May 17, HHS’s Office for Human Research Protections (OHRP) and FDA issued a joint, final guidance on written procedures for institutional review boards (IRBs).
The European Commission is looking into several parallel imports cases, including in the life sciences industry, with a view to opening formal antitrust investigations, which may eventually lead to fines being imposed. The pharmaceutical sector is understood to be under scrutiny in at least one of the current informal investigations, according to a leak in
Since 2017, new merger control thresholds have been in effect in Germany and Austria which do not depend on the revenues generated by the parties but, rather, on the value of the transaction.
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
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
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
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
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
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,
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
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
FDA announced last week that it was withdrawing numerous draft guidance documents including its 2004 draft guidance on disease awareness activities
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.
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
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
On 18 June 2014, the Food and Drug Administration issued two long-awaited draft guidances concerning Internet, social media, and search engine communications for prescription drug and medical device companies. Read More: FDA Provides New Framework for Drug and Device Promotion on Twitter and Search Engines
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
Berkley Life Sciences, Hogan Lovells, and Bowman and Brooke would like to invite you to a 60-minute webinar on Generic Drug Labeling, Product Liability, and the Changing FDA Regulatory Landscape. The webinar will take place Tuesday, March 11, 2014 at 2:00 p.m. ET.
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
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