Last week’s McDonalds glassware recall is another example of the problem of heavy metals appearing in consumer products. The fast-food giant, in cooperation with the Consumer Product Safety Commission (CPSC), recalled its promotional Shrek glassware because of the elevated level of cadmium found in the glasses. Read more »

Spring is in the air, and it’s time for a trip to the Javits Center for the annual INTERPHEX conference and exhibition. The editors of Pharmaceutical Technology and BioPharm International have arranged a series of interviews during the conference. We’ll be talking to pharmaceutical professionals, information-technology experts, and regulators about current challenges in manufacturing and about what the future might bring. Read more »

One week after President Barack Obama signed the Patient Protection and Affordable Care Act (HR 3590), the sweeping healthcare reform legislation into law (Public Law No. 111-148), it is still an important task to evaluate the impact of the new law on the pharmaceutical industry. Last week we reported and commented on some of those implications, and this week we continue our analysis: provisions in the new legislation regarding comparative effectiveness research (CER) and the underlying shift to value-based healthcare. Read more »

Got a Form 483? Then you’ve got 15 days. Starting today, FDA will enforce its program that calls for a more timely review of its Form 483 Inspectional Observations. Under this program, a company has 15 days to respond to the observations cited in the agency’s Form 483, before the agency decides whether to issue an official warning letter. The goal of this program is to optimize FDA’s already strained resources and to move firms to promptly correct noted violations. Read more »

Last week, the Biotechnology Industry Organization (BIO) and the Generic Pharmaceutical Association (GPhA) released dueling statements about the proposal to establish an approval pathway for follow-on biologics that the Senate Committee on Health, Education, Labor, and Pensions (HELP) is considering. Are the two antagonists advancing the debate? Read more »

Reports of teenagers’ pharm parties, Rush Limbaugh’s OxyContin addiction, and the questions surrounding Michael Jackson’s death have kept prescription-drug abuse in the public eye. By requiring manufacturers of opioid drugs to create risk evaluation and mitigation strategies, the US Food and Drug Administration is seeking to reduce opportunities for drug abuse while keeping the therapies available to patients who need them. One pharmaceutical company suggests that, in addition to regulatory solutions, drug abuse could be curbed using drug-delivery strategies. Read more »

The US Food and Drug Administration today warned consumers to stop taking three over-the-counter versions of Zicam, made by Matrixx Initiatives (Scottsdale, AZ). The company has received a Warning Letter, but a product recall has not been issued. Read more »

The US Food and Drug Administration’s transparency task force promises to raise questions about why certain manufacturer information on drug products is kept secret. Read more »

Speakers’ comments at the Parenteral Drug Association’s Annual Meeting, held in Las Vegas on Apr. 20-24, 2009, reflected the crisis that pharmaceutical and biopharmaceutical industries face. Presenters alluded to a cloud of challenges (e.g., cost pressures, products that can be duplicated by competitors, and quality-control failures) that has been gathering for some time. Several speakers claimed that small- and large-molecule manufacturers must change now to survive in the short and long terms. But change how? Read more »

Apparently, the Bextra (valdecoxib) nightmare is lingering a bit longer for Pfizer. More than four years after the initial lawsuits against the drug were filed, a sales executive of a separate company pleaded guilty yesterday to encouraging her sales staff to promote the painkiller for uses she knew had been rejected by the US Food and Drug Administration. Read more »