Amy Ritter, PhD

The justice department announced that Merck has agreed to pay $950 million to resolve criminal charges and civil claims related to its promotion and marketing of the painkiller Vioxx.

On Nov. 17, 2011, a bill that would increase penalties for those convicted of trafficking in counterfeit drugs was introduced in the House of Representatives. The Counterfeit Drug Penalty Enhancement Act of 2011, cosponsored by four US Senators and two US Representatives.

AstraZeneca, Bayer, Sanofi, Tibotec, TB Alliance, and the World Health Organization agreed to share information on tuberculosis compounds within their respective drug pipelines, according to the Critical Path to TB Drug Regimens. The purpose of the agreement is to promote information sharing around scientific and clinical studies so that partners can identify opportunities to test compounds in combination.

In response to the increase in drug shortages over the past three years, President Obama issued an executive order on Oct. 31, 2011 that directs FDA to take several steps to prevent and reduce drug shortages.

Merck, Sharpe, and Dohme (MSD) and Singapore's Economic Development Board jointly announced plans for significant investments by MSD to improve its existing manufacturing facilities in Singapore, as well as for new manufacturing, marketing, and research activities.

At the request of the US Senate Subcommittee on Federal Financial Management, Government Information, Federal Services, and International Security, the Government Accountability Office conducted an investigation into doctor shopping in Medicare Part D.

In response to concerns about the sustainability of US drug-development efforts, FDA has released a report that outlines several steps that FDA will take to spur biomedical innovation and ensure that such innovation can be quickly translated into safe and effective therapies.

The CRO Pharmaceutical Product Development (PPD) will be acquired by the Carlyle Group and Hellman and Friedman in a deal valued at approximately $3.9 billion. PPD shareholders will receive $33.25 per share in cash, and PPD will become a privately held company after completion of the transaction.

Single-use components in the fill–finish line provides increased flexibility to multiproduct manufacturers.

FDA has issued a guidance titled User Fee Waivers, Reductions and Refunds for Drug and Biological Products that outlines FDA's policies for issuing waivers, refunds or reductions in prescription drug user fees.

President Obama released his plan for deficit reduction on Sept. 19, 2011, and included in the 80-page report are several provisions that would affect US drug makers if enacted.

Novo Nordisk announced the roll-out of its Changing Diabetes in Children program in India, making India the seventh country to participate.

Representatives from FDA, the Generic Pharmaceutical Association, the European Fine Chemicals Group, and a task force from the Society of Chemical Manufacturers and Affiliates are nearing completion of draft legislation for the Generic Drug User Fee Act.

In 2010, FDA recorded nearly 180 drug shortages, triple the number recorded in 2005. Most of the drugs that experienced shortages were sterile injectables, including cancer medications and anesthetics.

In its latest filing with SEC for the quarter ending July 2011, Pfizer indicated that it has voluntarily provided the SEC and DOJ with information concerning potentially improper payments made by Pfizer and Wyeth in connection with sales activities that took place outside of the United States.

Since the passage of the BPCI Act in 2009, manufacturers have been waiting for guidance from FDA on what that approval process will look like.

FDA announced in late July the 2012 user fees collected under the Prescription Drug User Fee Act of 2007.

The age of globalized industry should result in fewer barriers between countries, but in practice it is rarely that straightforward, according to a report by ScienceInsider.

A bill introduced by Senators Scott Brown (R-MA), Ron Wyden (D-OR), and John McCain (R-AZ) on July 13, 2011, aims to encourage states to reduce Medicaid spending by offering financial incentives to substitute generic drugs for branded ones where possible.

Recent trends in the US biopharmaceutical industry suggest this is a pivotal area for potential job creation.

FDA issued a draft guidance, entitled "Q11 Development and Manufacture of Drug Substances," which is now available for comment according to a notice published on June 29, 2011, in the Federal Register.

Members of the House Energy and Commerce Committee are expanding their investigation into the 2008 entry of contaminated heparin from China into the United States market.

A subsidiary of Johnson & Johnson initiated a voluntary recall of its antipsychotic medication, Risperdal, due to an unusual odor.

An FDA guidance has provided information for products that involve the application of nanotechnology, and rationales for those points.

A South Carolina court found that a subsidiary of Johnson & Johnson violated state consumer protection laws by using misleading marketing for its antipsychotic drug, Risperdal.

More sophisticated biological expression systems expand the functionality of the traditional systems for protein synthesis.

Mylan, a generic-drug manufacturer, announced that it will be rebranding its Hyderabad, India-based subsidiary, Matrix Laboratories, as Mylan.

America's pharmaceutical research and biotechnology companies are developing 851 medicines for diseases that disproportionately affect American women, says a PhRMA report.

A bill was introduced in the US House of Representatives to launch a national strategy for the development of regenerative medicines.

FDA issued a new guidance for industry concerning the submission of summary bioequivalence data for abbreviated new drug applications.