New FDA Team to Spur Modern Drug Manufacturing

To encourage adoption of advanced manufacturing technologies that can help industry meet high quality standards consistently, and avoid drug recalls and shortages, FDA’s Center for Drug Evaluation and Research is establishing an Emerging Technology Team (ETT) to assist innovative manufacturers in navigating the regulatory process and overcome roadblocks. The new team will facilitate the inspection and review of manufacturing facilities where modern pharmaceutical development and production approaches are involved, explained Mansoor Khan, director of the division of product quality research in CDER’s Office of Testing and Research (OTR). Khan noted at the PDA/FDA annual regulatory conference in September that the ETT also would share information on new approaches in manufacturing quality with other regulatory authorities to encourage common oversight approaches to modern pharmaceutical production over the long term.

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Sandoz Wins Biosimilar Filing Race

After months of speculation about prospects for biosimilar development in the United States, Novartis announced on July 24 that FDA has accepted Sandoz’ biologics license application (BLA) for a similar version of Amgen’s Neupogen (filgrastim). Assuming FDA approval within a year, this action sets the stage for testing whether and how biosimilars will gain acceptance in the US healthcare market, and the impact these products will have on new drug development and product pricing and marketing.

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Medicare Payment Data Raises Questions About Drug Costs

Even though the just-released Medicare data on payments to individual doctors

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FDA Wants You!

A number of top management positions at the Center for Drug Evaluation and Research (CDER) need to be filled, and CDER leaders are looking for experienced industry managers to help rebuild its staff.

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Many experienced FDA staffers are ending their careers or taking on new challenges, creating a need for “renewal and replenishment of the agency,” explains Richard Moscicki, deputy director for science operations at CDER, who is leading its executive recruitment campaign. Moscicki formerly headed clinical development at Genzyme before coming to FDA in February 2013 and hopes to attract more people with similar backgrounds to public service. While some positions may be filled by internal candidates, Moscicki is looking to bring in people with leadership and management experience that may not exist at the agency.

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Drug-Diagnostic Development Stymied by Payer Concerns

The shift to personalized medicine, which supports medical treatment tailored to individual patient characteristics, has been hindered by uncertainty over the value, accuracy, and clinical utility of companion diagnostic tests. Even for the handful of drugs approved by FDA with labeling that links prescribing to specific biomarker measures, health plan operators, providers, and payers

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Track-and-Trace Not Enough to Halt Drug Counterfeiters

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Drug Shortages Continue to Plague Healthcare System

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PDA Panel Proposes Limited Set of Metrics to Measure Quality Trends

If FDA is going to establish standards for assessing the quality of manufacturing sites and products, it should seek data on a few well-defined measures that reflect longer-term results and trends, rather than “snapshots of current numbers.” And such metrics should include more leading—vs. lagging—indicators to reflect a firm’s commitment to continuous improvement in production processes. Those recommendations come from a PDA “points to consider” paper, written to help FDA set standards to measure product quality and manufacturing capabilities.

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FDA Approves Fewer New Drugs, But Acts Fast on Innovative Products

As expected, FDA approved only 27 new molecular entities (NMEs) in 2013. There was no late-December surge in approvals to bring the tally closer to the near record of 39 innovative new drugs approved in 2012. In addition, the Center for Biologics Evaluation and Research (CBER) approved eight novel products, including innovative influenza vaccines and a number of blood products.

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Provider Demand to Drive Compounder Registration with FDA

FDA is moving fast to implement the drug compounding provisions of the new Drug Quality and Security Act (DQSA), issuing new guidance to spur registration by outsourcing facilities just days after President Obama signed the new bill into law. Because FDA cannot compel compounders to opt for agency regulation, implementation will rely largely on market pressures to encourage healthcare providers to purchase compounded products only from registered facilities, explained FDA commissioner Margaret Hamburg at a press briefing Dec. 2, 2013.

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