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Tag Archives: pharmaceutical

FDA and DoD strengthen collaboration for medical products with military applications that could also be expanded to the general population

On November 2, FDA and the Department of Defense’s (DoD) Office of Health Affairs signed a Memorandum of Understanding (MoU) that formally establishes the framework under which the DoD and FDA will implement  Public Law 115-92, which was enacted in 2017.  The law gives the DoD new opportunities to advocate to FDA for expedited development,

FTC takes on deceptive stem cell therapy claims for blindness cure and autism treatment

On October 18, the Federal Trade Commission (FTC) announced it settled charges against California-based Regenerative Medical Group, Telehealth Medical Group, and the founder of both companies, Dr. Bryn Jarald Henderson, based on deceptive stem cell therapy claims.  In its complaint, the FTC alleged Henderson and the companies made unsupported claims, including that “amniotic stem cell

12 Years Later: Court Prohibits Marketing of Prescription Versions of OTC Drug

In a big win for the Food and Drug Administration (FDA), the D.C. Circuit of the United States Court of Appeals reinforced FDA’s position on what constitutes a “meaningful difference” between prescription and over-the-counter (OTC) versions of a drug product.  Under FDA’s longstanding interpretation, section 503(b) of the Food, Drug, and Cosmetic Act (FDCA) “does

Trump touts “historic” plan to overhaul Medicare payments, create International Pricing Index

President Trump today touted “bold” plans to lower drug prices in unspecific terms.  Simultaneously, CMS issued an Advance Notice of Proposed Rulemaking (ANRPM), describing options to test Medicare reimbursement based on an “International Pricing Index” (IPI), under which U.S. drug prices would be benchmarked against 16 other countries that reportedly have lower drug prices.  This

A broader definition of “unmet needs” has been proposed to support the development of anti-bacterial medicinal products

The concept paper The EMA has published a “Concept paper on preparation of a revised guideline on the evaluation of medicinal products indicated for treatment of bacterial infections.” In the Concept Paper, the EMA proposes to merge the “Guideline on the evaluation of medicinal products indicated for treatment of bacterial infections (CPMP/EWP/558/95 Rev 2)” with

CMS proposes requiring drug prices in TV ads

On October 15, CMS released a proposed rule titled “Medicare and Medicaid Programs: Drug Pricing Transparency,” which would require direct-to-consumer (DTC) advertisements for prescription drugs covered by Medicare or Medicaid to include the Wholesale Acquisition Cost (WAC).  This proposed rule resembles a rejected Senate amendment to the FY-2019 Labor-HHS-Education appropriations bill (analyzed here) that would

FDA publishes internal policy on prioritizing surveillance inspections for drug manufacturing sites

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

U.S. Senate passes bill requiring prescription drug ads to include prices (updated)

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

FDA launches Biosimilars Action Plan to spur biologics competition, finalizes labeling guidance

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

The European Commission Is Considering Opening an Antitrust Probe for Parallel Imports in the Pharmaceutical Sector

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

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