In 2010, the US House of Representatives’s Committee on Oversight and Government Reform held two hearings after scandalous cGMP violations at McNeil’s Puerto Rico facilities came to light. Former FDA Deputy Commissioner Joshua Sharfstein told the Committee that the agency would review McNeil’s plan for correcting deficiencies to ensure that the corrective actions were effective. “FDA intends to keep a close eye on these facilities until the company earns our confidence back,” said Sharfstein. Read more »

Despite the impending danger of the looming ash cloud from Iceland’s Grimsvotn volcano, and with complete disregard for my own personal safety, I attended the second and final day of the 7th European Downstream Technology Forum earlier this week. Hosted at the Sartorius College in Goettingen, Germany, such was the quality of the speakers that most people simply forgot about the potential for travel mayhem and focused entirely on the subject at hand. Read more »

KV-Pharma’s ill-advised pricing of its FDA-approved synthetic progesterone has caused Congress to scrutinize the pricing of other newly-approved versions of old drugs. In an effort to bring such legacy medications into compliance with modern requirements for drug safety and efficacy, FDA offers incentives in the form of patent protection to companies that run older drugs through the appropriate clinical trials and seek FDA approval. URL Pharma markets an FDA-approved gout medication called Colcrys, the active ingredient of which is colchicine, a medication so old that it predated the FDA’s drug safety laws. URL Pharma won approval for their drug in July 2009 and set the price at almost $5 a pill compared with pennies a pill for unapproved versions of colchicine, which FDA ordered be removed from the market once the approved drug became available. URL Pharma vigorously defended their patent after approval and also defended their pricing, saying that it was in line with other approved gout medications and that running the clinical trials provided important safety and dosage information.

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FDA may soon revise the labeling of over-the-counter pediatric medications to place a stronger emphasis on weight rather than age for dosing instructions. In mid-May, two advisory committees to the agency, the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee, recommended a change for children’s OTC medicines that contain acetaminophen, such as Tylenol. The labeling issue has been a concern for many years now, and has gained attention since January 2008, when postmarket adverse events were reported for McNeil Consumer Healthcare’s pediatric formulations of Tylenol, Motrin, Zyrtec, and Benadryl. Read more »

Finding ways to fund drug development and commercialization is an ongoing task for the pharmaceutical industry. Although devising financing plans and securing  funding is a mainstay function of emerging and smaller biopharmaceutical companies, it also can  be a task for larger pharmaceutical companies as they evaluate, prioritize, and fund their pipelines and commercial drugs. A case in point is Eli Lilly, which announced this week that it has signed a deal with private investors to form a new biotechnology company with a focus on hospital-based critical care medicines.

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Makers of small-molecule drugs are in treacherous waters. The Scylla of generic-drug competition rears on the horizon, ready to bite into innovators’ profits. At the same time, companies’ research-and-development productivity seems to have been sucked down into Charybdis. How will drugmakers survive these perils? Read more »

New analysis from IMS Health has painted a gloomy picture for branded medicines for the next five years as patent expiries and national policy changes take their toll. Spending for branded products in developed markets will remain at the same level in 2015 as in 2010; however, the market share for branded medicines, which fell from 70% in 2005 to 64% in 2010, is expected to decline to 53% by 2015. Read more »

A minority shareholder in Forest Laboratories, the AFL-CIO, has called for the resignation of the company’s CEO, Howard Solomon. Last month, the Office of the Inspector General (OIG) issued a letter to Solomon, notifying him that they were considering excluding him from participation in federal health care programs, such as Medicare, Medicaid, and the VA. He was given 30 days to reply in writing with a justification as to why he should not be excluded.

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FDA and EMA released plans this week for their pilot program to co-review new drug applications (NDAs, known as marketing authorization applications, or MAAs, in Europe) that are developed with a quality-by-design approach. According to the announcement, QbD approaches are raising new scientific questions because they require statistical, analytical, and risk assessment methods that have not historically been applied. For example, there are questions around defining a design space, applying real-time release testing, and implementing a continuous process. The pilot, which took effect April 1, 2011, will last for three years, and will operate under confidentiality agreements between the US and European Union. Read more »

Attendant to the pharmaceutical industry’s intensification in biopharmaceutical product development is the need for more effective delivery systems for large molecules. Oral administration, the widely used and common method for small-molecule drug delivery, is not a viable option for biologic-based drugs, so how can parenteral drug delivery be improved to make it easier to administer and potentially more patient- friendly? One approach, intradermal microinjection, recently took a step forward with FDA approval of an influenza vaccine delivered via this method. Read more »