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
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
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
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
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 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 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).
In recent years competition authorities in a number of EU Member States have stepped up in their pursuit against companies active in the Life Sciences sector for excessive pricing. Last week, the European Commission issued a press release signalling that it will not be left behind on the action when it launched a probe into
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
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
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.
The U.S. Department of Health and Human Services (HHS) held a forum on Friday, November 20 entitled, “HHS Pharmaceutical Forum: Innovation, Access, Affordability and Better Health.” Read More: HHS Pharmaceutical Forum: “Innovation is Meaningless if No One Can Afford It”
On 1 July 2015, the new common logo for online pharmacies and retailers offering medicinal products for human use in the European Union (“EU”) will come into effect. The purpose of the logo is to contribute to reduction in the threat of the circulation of falsified medicinal products. It is anticipated that the logo will enable customers to identify persons who are authorised or entitled to sell medicinal products at a distance to the public through a website.
In 2014 there were a number of significant antitrust developments for the pharmaceutical industry.
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.
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).
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:
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
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
The New York Attorney General’s (NYAG) office has announced that it has reached a settlement with two generic drug manufacturers regarding allegations that an agreement between the firms not to challenge each other’s eligibility for regulatory exclusivity was anticompetitive. Although not a traditional reverse payment patent settlement agreement between branded and generic drug companies, the
Recently, a federal judge in the U.S. District Court for the District of New Jersey held that only patent settlements involving a reverse monetary payment will be subject to antitrust scrutiny under the framework articulated by the Supreme Court last year in FTC v. Actavis. In affirming its earlier ruling dismissing the direct purchaser complaint,
In testimony before the Senate Judiciary Committee yesterday, new FTC Chairwoman Edith Ramirez stated that agency staff will re-examine pharmaceutical patent settlement agreements previously filed with the FTC in order to determine if any warrant investigation or challenge in light of the Supreme Court’s recent ruling in FTC v. Actavis, which held that such agreements