The day of reckoning is here. As patent protection expires for top-selling drugs, some firms are scrambling to stay one step ahead of generic-drug competitors. As Amy Ritter wrote last week, Pfizer is drawing scrutiny by asking pharmacy benefit managers to block pharmacies from filling prescriptions with generic alternatives to Lipitor, in exchange for a discount on the product. Rep. John Sarbanes (D-MD) asked the Federal Trade Commission to take action against this arrangement, but another tactic is also causing concern. Read more »

When only a handful of manufacturers supply a given drug, production problems at any of those companies can lead to a shortage. Earlier this year, problems at Ben Venue’s Bedford, Ohio, site contributed to shortages of the cancer drug Doxil. The shortages are likely to continue now that Ben Venue has suspended manufacturing at the plant. Read more »

FDA approved 35 innovative drugs in fiscal 2011, including treatments for hepatitis C, prostate cancer, Hodgkin’s lymphoma, and lupus. This number of approvals is among the highest in the past 10 years, and it reflects the agency’s efforts to hasten patients’ access to new drugs. In the past two years, the agency’s lower levels of approvals—21 drugs in 2010 and 25 in 2009—caused concern throughout the industry and in Congress. We may feel grateful to FDA, but we also should ask how the agency achieved this high number of approvals.

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With 2011 sales of approximately $54.1 billion, Pfizer currently holds the crown as the world’s largest drugmaker, but next year may see the pharma giant usurped from its throne by Sanofi and Novartis, who will claim pole and second position respectively in the global pharmaceutical rankings. Pfizer, meanwhile, will drop to third place, and is likely to remain there for the foreseeable future, according to analysis firm EvaluatePharma. Read more »

It’s getting harder for the pharmaceutical industry to ignore neglected diseases. The globalization of national economies and the rise in air travel are increasing the potential for exposure to these diseases, which previously had been limited to the developing world. “Now is the time to have this discussion,” Kishor M. Wasan, chair-elect of the American Association of Pharmaceutical Scientists’s Pharmaceuticals in Global Health Focus Group, told Pharmaceutical Technology earlier this month. Industry now seems to be getting the message. Read more »

Worried about our persistently high rate of unemployment (and his bid for re-election), President Obama is urging Congress to pass portions of his jobs bill. In addition to aiding the economy, creating jobs could help reduce the number of people who are forgoing medications, which would be a boon for the pharmaceutical industry. Perhaps with this in mind, the Association of Clinical Research Organizations (ACRO) has thrown its weight behind a bill it says would create American jobs.

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The pharmaceutical industry has sometimes been slow to embrace ideas that promise great practical benefits. The industry’s ingrained aversion to risk is partly to blame, but it’s usually not the whole story. Take the quality-by-design (QbD) initiative, which posits that the better a company understands a product’s quality attributes, the more likely that product will be safe and efficacious. The industry has generally supported this initiative, and Pfizer has brought it into the spotlight. Read more »

Big Pharma’s sales forecast is not likely to improve anytime soon. Consulting firm Bain and Company predicts that the top 25 drug companies’ annual sales growth will be no more than 1% through 2016. To compensate for reduced revenue, investors are urging manufacturers to cut expenses that do not add value. One such expense, in many investors’ eyes, is research and development (R&D). Read more »

Mention New Jersey to someone on the street, and he or she is likely to think of Springsteen, the Sopranos, or (God forbid) Snooki. But PharmTech readers know that New Jersey is an important state for the drug industry. Many big companies, such as Johnson and Johnson, sanofi-aventis, Novartis, and Pfizer, have headquarters or other offices in the state. And the Garden State’s drugmakers are facing the same difficulties that confront the industry at large. Read more »

Big Pharma has offered many explanations for its anemic pipelines. All of the easy drugs have been discovered. Patent law (or another particular form of regulation) stifles innovation. The economy is forcing us to retrench. Although these explanations may be plausible, they all lay the blame elsewhere. Could Big Pharma’s own actions be discouraging research and development (R&D)? Read more »