Revisions to the United States Pharmacopeia (USP) General Chapter<231>Heavy Metals have been much discussed over the past decade. USP is in the process of replacing this chapter with General Chapters <232> Elemental Impurities—Limits and <233> Elemental Impurities—Methods, which were published in USP 35-NF 30, Second Supplement. The official date for the new chapters—originally Dec. 1, 2012—was briefly postponed due to an appeals process but was recently re-established as Feb. 1, 2013, as described in today’s PharmTech news article.
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With the release of a draft guidance on the evaluation and labeling of abuse-deterrent opioid formulations, FDA is one step closer to clarifying its thinking on acceptable formulations for this product class. Read more »

PharmTech’s February issue will feature a guest editorial by Aaron Davidson, a partner in the life sciences practice at Baker Botts, on social media and the pharmaceutical industry. In his editorial, Mr. Davidson points to FDA and a lack of regulatory guidance as the reasons that social media has not caught on in the pharma and bio/pharma industries. FDA’s requirement to provide consumers with FDA-approved promotional materials that contain risk information may limit a pharmaceutical company’s ability to use mediums such as Twitter and Facebook effectively.

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PharmTech’s March issue will feature an update on process analytical technologies that will include a focus on validation. As part of my research for the March feature, I would like to know your answer to the following question.

How has the FDA process validation guidance, Guidance for Industry: Process Validation: General Principles and Practices, changed validation in pharmaceutical manufacturing?

Please send your answers to shaigney@advanstar.com or post them directly here in the comments section.

Thank you!

On the second day of the PDA/EMA joint conference, we had a choice of three different topics, all running simultaneously: GMP inspection practice, process and validation, and challenges for EU harmonisation. I somehow found myself listening to Lina Ertle from the French national agency for medicines and health products (ANSM), who gave an update on process validation guidelines. Read more »

Last week, I attended the PDA/EMA joint conference in Cascais, Portugal. The topic was on compliance, a prerequisite for availability of medicinal products. The conference kicked off with a plenary session on the impact of the new falsified medicines directive (FMD) on regulators and the pharmaceutical industry. Belen Escribano Romero from the AEMPS (Agencia Española de Medicamentos y Productos Sanitarios), a public body that belongs to the Spanish Ministry of Health, provided an overview of the main changes in the new legislation, which included, amongst others, the importation of APIs and excipients from third-world countries, inspection planning, revisions of the GMP guidelines, new GDP guidelines for the distribution of medicinal products by wholesalers and brokers, as well as pending regulations relating to safety features and purchasing medicines via the internet. It is hoped that these additional requirements will increase the quality of medicinal products, reinforce supply-chain security and prevent penetration of counterfeits, and better protect those buying medicines online. Read more »

Yesterday, FDA Commissioner Dr. Margaret Hamburg testified before the House Energy and Commerce Committee on the fungal meningitis outbreak. The purpose of the hearing was to determine why contaminated medicines entered the supply chain so that future occurrences could be prevented. Read more »

Last week, Merck agreed to settle a Missouri consumer class-action suit, which claimed the company violated the Missouri Merchandising Practices Act when it promoted and sold its pain reliever Vioxx. Merck removed Vioxx from shelves in 2004 due to evidence that it increased the risk of heart attacks.  According to the Justice Department, Merck began marketing Vioxx as a treatment for rheumatoid arthritis shortly after being approved by FDA as a painkiller in May 1999. However, FDA had not approved it for the treatment of rheumatoid arthritis until 2002. The settlement is reportedly for $220 million and Merck agreed to pay validated claims as well as approved attorneys’ fees, and settlement notice costs.

Merck’s press release on the settlement didn’t mention any admission of wrongdoing. In a company press release, Bruce N. Kuhlik, Merck’s executive vice-president and general counsel, said “This agreement is in the best interest of the company and its shareholders. It reduces the uncertainty of litigation and ongoing defense costs, and helps us to remain focused on bringing forward innovative products and services for our customers.” This is one of several recent examples of off-label drug promotion. Are the millions pharma companies end up paying in lawsuit payouts worth sidestepping FDA rules?

FDA has pushed back goals in relation to the Prescription Drug User Fee Act (PDUFA), the Biosimilar User Fee Act (BsUFA), and Medical Device User Fee Act (MDUFA) as a result of the closing of agency offices during Hurricane Sandy. FDA says it will assess the goals that were due October 31 and extend them as needed. The extensions will be no more than the number of business days the agency was closed.

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