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Focus on Regulation

Tag Archives: Pharmaceuticals

Federal Circuit Acetris Decision Changes Procurement Country of Origin Landscape

On Monday, in the much-anticipated decision in Acetris Health, LLC v. U.S. 18-2399, the Court of Appeals for the Federal Circuit (the “Federal Circuit”) ruled that U.S. manufacture of a drug is sufficient to confer U.S. origin under the Trade Agreements Act (“TAA”) – regardless of the origin of its main component, the Active Pharmaceutical

FDA introduces new standardized inspection protocols for sterile drug manufacturers to modernize and strengthen oversight

On November 9, FDA Commissioner Scott Gottlieb, M.D., announced that the agency launched new inspection protocols for aseptic processing of sterile drugs to be used by FDA investigators during surveillance and pre-approval inspections.  The protocols were developed through the agency’s New Inspection Protocol Project (the “NIPP”), initially launched in 2014.  The NIPP is intended to

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

UK Parliamentary Report Published on the Impact of Brexit on the Pharmaceutical Sector

The Business, Energy and Industrial Strategy Committee, a parliamentary select committee, has published a report on the consequences of Brexit on the UK pharmaceutical industry. The report examines the impact of different outcomes of the UK/EU negotiations, including a “no deal” scenario, on tariff barriers, non-tariff barriers (e.g. border delays), regulatory alignment, trade opportunities, skilled

The evolution of CBD in South Africa

During the past several decades, the advances made in the life sciences and health care industries have been astounding, not to mention revolutionary. A presently obscure and experimental treatment may, in a day or week or years’ time, become a miraculous cure. Imagine the ridicule faced by Peyton Rous when he suggested that cancers have

New Legislation Increases Access to Medical Products for Military Applications

Today, the President signed new legislation that gives the Department of Defense (DoD) new opportunities to advocate to FDA for expedited development, review, and Emergency Use Authorization (EUA) for medical products that could help protect and treat U.S. military forces.  The legislation was developed as an alternative to a provision in the National Defense Authorization

FDA to Rely on Drug Inspections Performed by Certain European Regulatory Authorities Beginning November 1, 2017

Earlier today, FDA announced that it has determined that the regulatory authorities of Austria, Croatia, France, Italy, Malta, Spain, Sweden, and the United Kingdom are “capable of conducting inspections of [pharmaceutical] manufacturing facilities that meet FDA requirements,” and that the Agency will begin relying “on the inspectional data obtained by these eight regulatory agencies” immediately. 

FDA Launches New Tool For Accessing Drug Adverse Event Information

FDA recently launched a public dashboard within the FDA’s Adverse Event Reporting System (FAERS) to improve access to data on adverse events related to drug and biological products.  FDA Commissioner Scott Gottlieb, M.D. stated, “Tools like [FAERS] are critical to the FDA’s ability to help ensure the greatest level of transparency and help patients and

The life sciences industry under the antitrust spotlight in China: two practical points

The simple fact is that the Chinese antitrust regulators are determined to up their enforcement activities in the life sciences industry. Almost immediately after drug pricing was liberalised in 2015, an antitrust enforcement decision was announced against a government entity, a local health commission, for breaching a number of provisions in the Anti-Monopoly Law (AML).

Outlook for Disgorgement Remedies in the Trump Administration

With the departure of now former Chairwoman Edith Ramirez earlier this month, among the most discussed vacancies in the new administration these days is the post of permanent Chair of the Federal Trade Commission. According to reports, one leading candidates is Acting Chairman Maureen Ohlhausen, and her selection could also have significant implications for FTC

MHRA Publishes Draft Guidance on GxP Data Integrity

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published for public consultation a draft guidance on GxP Data Integrity which includes definitions of key terms. The draft Guidance applies to both paper and electronic data in all areas of GxP (good laboratory practice, good clinical practice, good manufacturing practice, good distribution practice and

FDA Clarifies Expectations for Use of Electronic Health Records in Clinical Investigations

On May 17, 2016, FDA published a Draft Guidance for Industry regarding use of electronic health records (EHRs) in clinical trials, building on previously issued guidance on computerized systems and electronic source data used in clinical investigations. As summarized below, this Draft Guidance provides a number of important recommendations to study sponsors who rely on electronic data that are generated and maintained by healthcare facilities in the routine care of patients.


On 27 November 2014, the European Medicines Agency (“EMA”) published its new guideline on the pharmacokinetic and clinical evaluation of modified release dosage forms (the “Guidelines“). Modified release dosage forms are formulations where the rate and/or site of release of the active ingredients are different from that of the immediate release dosage form administered by


The European Medicines Agency (“EMA”) has published its Guide on access to unpublished documents (the “Guide”).

In accordance with European Union (“EU”) law, any person may request access to unpublished documents held by the EMA. The Guide is intended to provide practical guidance concerning the process for requesting access to these documents. The new Guide is in the form of a Questions and Answers document and includes a flow chart of the access-to-documents process.

New Charter in France for Pharmaceutical Promotion

The CEPS (French Health Products Economic Committee) and LEEM (French Pharmaceutical Industry Association) signed on 15 October 2014 a new Charter on information provided for promotional purposes via solicitation or prospection. This charter had been in discussions since 2013. It replaces and broadens the scope of the previous charter applicable to medical representatives’ activities. The


On 5 September 2014, the European Commission released the Implementation report on the Commission Communication on Rare Diseases: Europe’s challenges (COM(2008) 679 final) and Council Recommendation of 8 June 2009 on an action in the field of rare diseases (2009/C 151/02) (the “Implementation Report”).

As part of the European Commission’s drive to take action concerning rare diseases, the Implementation Report analyses the extent to which the Commission’s measures on rare diseases have been established.

The Implementation Report provides an overview of the European Union (“EU”) rare diseases strategy to date, including the Commission Communication (COM(2008) 679 final) and Council Recommendation (2009/C 151/02).

340B Program: U.S. District Court for the District of Columbia Vacates HRSA’s Final Rule on the 340B Orphan Drug Exclusion

On Friday, May 23, 2014, the U.S. District Court for the District of Columbia “vacated,” or invalidated, the Health Resources and Services Administration’s (HRSA) final rule on the treatment of orphan drugs under the 340B Drug Discount Program. HRSA, which administers the 340B program, released the final rule in July 2013. Read More: 340B Program:

Defining “Payments”: The First Post-Actavis Battleground in Pharmaceutical Reverse Payments

In June 2013, the Supreme Court ruled in FTC v. Actavis  that reverse-payment pharmaceutical patent settlement agreements  are subject to rule of reason analysis under the antitrust laws.  In doing so, the Court not only rejected both the FTC’s position that such agreements should be presumptively unlawful and the position of pharmaceutical manufacturers that such agreements

Actelion Settles REMS Dispute with Generic Drug Manufacturers

Last week Actelion settled a lawsuit against two generic drug manufacturers regarding whether Actelion is required to supply those generic firms with samples of its drug Tracleer for use in the bioequivalence testing required as part of abbreviated new drug applications (ANDAs).  Tracleer is subject to various distribution restrictions as part of its Risk Evaluation