Memo to Congress: Hands off FDA

Erik Greb PharmTech editorIn January 2011, control of the US House of Representatives will shift to the Republican party. Reducing the federal deficit is one of the party’s top priorities, and Republican leaders have proposed to cut domestic spending as a means to accomplish this end. But should all programs be put on the chopping block? Read more »

Of Genes, Coal, and the US Government

Erik Greb PharmTech editorBiopharmaceutical manufacturers have successfully patented isolated DNA molecules for some time. The Biotechnology Industry Organization recently described these patents as critical tools that enable the research and development of new biotech therapies. A new development in a federal court case, however, could redefine what legitimately can and cannot be patented. The court’s decision could have ramifications for all biopharmaceutical manufacturers. Read more »

FDA Needs More Muscle and Money

Erik Greb PharmTech editorThe welter of recent product recalls (and phantom recalls) initially got the US Congress talking about the adequacy of Johnson and Johnson’s (J&J, New Brunswick, NJ) manufacturing and quality-control operations. But lawmakers soon began asking questions about our line of defense against potentially harmful products: the US Food and Drug Administration. Read more »

Pfizer Fights Transparency

Erik Greb PharmTech editorPatients rely on doctors to make impartial decisions about the most effective treatments for their conditions. In recent years, public advocates have agitated for restrictions on pharmaceutical companies gifts’ (e.g., meals, honoraria, or entertainment) to medical professionals on the grounds that they could unduly influence prescribing habits. In what seems like a fight against transparency, Pfizer (New York) sent employees to Connecticut’s capitol to protest a state bill that would restrict such gifts and require reporting. Read more »

BIO–1, GPhA–0

Erik Greb PharmTech editorThe Biotechnology Industry Organization (BIO) has won the latest battle over follow-on biologics. Last week, the House Energy and Commerce Committee approved Rep. Anna Eshoo’s (D-CA) amendment to the America’s Affordable Health Choices Act (H.R. 3200). The Eshoo amendment, a regulatory pathway for the approval of biosimilars, would grant about 12 years of market exclusivity to each new biological medicine. Read more »

Chutes, Ladders, and Healthcare Reform

Erik Greb PharmTech editorCongress has taken up the Obama administration’s goal of making healthcare more affordable by introducing various strategies for reducing the cost of prescription drugs. But the Pharmaceutical Research and Manufacturers of America and the Biotechnology Industry Organization (BIO) have resisted several of Congress’s initiatives, and cost control has been elusive so far. Read more »

Drugs for Breakfast?

Erik Greb PharmTech editorNews reports about adulterated drugs seem to have been replaced by stories of contaminated food products. Cases of salmonella related to products that contain peanuts and pistachios are the latest examples. The US Food and Drug Administration has been blamed for failing to protect consumers, and commentators have cited outdated policies, inadequate staffing, and insufficient funds.

In February 2009, Rep. Rosa DeLauro (D-CT) proposed creating a separate Food Safety Administration to improve oversight of food products sold in the United States. But a recent FDA Warning Letter suggests that drawing a line between food and drug products might not be so simple. Read more »

Are Facility Inspections a Zero-Sum Game?

Erik Greb PharmTech editorPerhaps out of embarrassment at the stream of incidents involving contaminated products, the US Food and Drug Administration has requested the largest budget increase in its history. The agency intends to use part of the funds for its proposed Safer Medical Products initiative, which will scrutinize domestic and imported drugs. Will it use the money wisely? Read more »

« Previous Page