As part of Ranbaxy’s recently announced consent decree, the company is required to set up a program whereby whistleblowers can come forward with information related to potential violations of the Food, Drug, and  Cosmetic Act. According to the decree, available through Pharmalot’s post, Ranbaxy must, within 75 days, establish a phone line and a system to receive and maintain submissions from individuals wishing to report suspected violations. The submissions are required to be confidential, there should be no retaliation, and a good-faith effort must be made to investigate any allegations. Read more »

Earlier this week, Novo Nordisk launched a diabetes initiative in the US that stars the celebrity chef Paula Deen. Usually, it’s the pharma company that gets the sharp end of the stick when it comes to criticism but this time the negative attention has fallen on Deen, with Norvo Nordisk barely getting a mention in many news sources. Read more »

New Jersey is known to many as a pharmaceutical mecca on the international stage with several leading pharmaceutical majors headquartered and/or with operations in the state. So to say that lawmakers need to create an economic climate conducive to foster growth is an understatement.

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According to a recent press release from the Department of Justice, the government has reached record highs in the recovery of fines settled under the False Claims Act. In 2011, over $3 billion were collected, bringing the total since January 2009 to $8.7 billion. This year’s total included $2.4 billion in recoveries involving fraud committed against federal health care programs. Read more »

Drug shortages are increasing at an alarming rate. Between 2005 and 2010, the number of drug shortages per year leapt from 61 to 178. This year’s total, 220 as of October, already surpasses that of last year. Fortunately, FDA has taken a step that is intended to prevent drug shortages from becoming crises. Read more »

Just when it seemed that controversy over the Plan B contraceptive was a thing of the past, the drug returned to the headlines. In an unprecedented action, Health and Human Services Secretary Kathleen Sebelius overruled FDA’s decision to allow Teva’s Plan B One-Step to be sold over the counter to girls under the age of 17. In a public statement, Sebelius said that about 10% of girls can bear children by 11.1 years of age. Teva’s “label comprehension and actual use studies did not contain data for all ages for which this product would be available for use,” she said. But FDA sees the matter differently. Read more »

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 »

On Nov. 30, 2011, the patent for Lipitor, the cholesterol-lowering drug that defined the term “blockbuster,” expired. Over its lifetime, it is estimated that Lipitor generated over $100 billion in sales for its parent company, Pfizer, since its introduction in 1997. Read more »

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 »