Economically motivated adulteration became a major concern after heparin manufactured by Baxter Healthcare was contaminated with oversulfated chondroitin sulfate. FDA told the Government Accountability Office (GAO) that getting information from industry about potential instances of economic adulteration is crucial to addressing the problem. Companies have been reluctant to share this information, but a GAO report suggests a possible solution. 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 Commissioner Margaret Hamburg held a special press briefing this morning on Genentech’s Avastin drug and its indications for metastatic breast cancer. She announced that the agency is revoking that indication based on FDA follow-up studies which did not show promising results. Read more »

Topical drugs are an important sector in the pharmaceutical market, particularly as pharmaceutical companies seek innovative ways to improve drug delivery and patient compliance. An upcoming webcast on Dec. 7th by Pharmaceutical Technology gains insight from leading industry experts on how to optimize topical drug formulations and manufacturing. Read more »

The US Supreme Court, as expected, will decide if key provisions of the Obama administration’s health care overhaul law violate the Constitution by exceeding the federal government’s power to regulate interstate commerce and to levy taxes. The key issue is whether Congress can require every American to purchase health insurance by 2014 or pay a penalty. State officials and other parties are challenging the constitutionality of the individual mandate provision in the Affordable Care Act (ACA), and differing legal rulings on the issue has brought it to the High Court for a final ruling. Read more »

Consortiums are nothing new, but they do seem to be popping up more than usual throughout the pharmaceutical sector lately. Rx-360 and its supply-chain efforts come to mind, as does the IQ consortium on advancing innovation in the quality of pharmaceutical development. There’s also an international pharmaceutical privacy consortium, a consultants consortium, and more.

The fact is, industry seems to be tired of waiting for standard-setting bodies and regulators to take action on solving key challenges such as counterfeiting, economically motivated adulteration, the implementation of quality by design, and so forth. It’s not that the agencies and organizations aren’t working on these issues, but they have to do deal with more legal and governmental bureaucracy than do representatives from various companies sitting around a table over coffee or drinks. 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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For those who are needle-shy, or who have ever had the pleasure of explaining to a hysterical 5-year old that the shot isn’t going to hurt THAT much, and besides, it’s for the good of public health, a needle-free shot sounds like a great idea.  FDA, however, disagreed, and issued a communication to that effect. Read more »

Written by A. Nair, a PharmTech correspondent based in Mumbai

After months of deliberation, the Indian government has decided not to cap foreign direct investment (FDI) in the pharmaceutical sector and to continue with the 100% FDI regime. A decision in this regard was taken by an inter ministerial group presided over by India’s Prime Minister Manmohan Singh, which sought to allay fears about clearing investments automatically. Read more »

As the unemployment rate hovers around 9.1%, the federal government needs to find ways to create jobs. Congress is debating whether a tax break on repatriated money would prompt companies to hire more workers, as I mentioned last week. Meanwhile, the Obama administration is eyeing another potential means of stimulating job growth: investing in biological research. Read more »