Amy Ritter, PhD

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.

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. The newly issued guidance is a revision of a 1993 guidance titled Draft Interim Guidance Document for Waivers of and Reductions in User Fees.

A Q&A with Rick Hancock, president of Althea Technologies. This article contains bonus online material.

Novo Nordisk announced the roll-out of its Changing Diabetes in Children program in India, making India the seventh country to participate. The aim of the program is to contribute to meeting the fourth UN Millennium Goal?to reduce child mortality?by breaking down the barriers that prevent children with Type I diabetes in developing countries from receiving proper care. The program is currently operating in six countries?Bangladesh, Cameroon, the Democratic Republic of the Congo (DRC), Guinea, Tanzania, and Uganda, and Novo Nordisk plans to launch the program in Kenya within the next few months.

In its latest filing with the Securities and Exchange Commission (SEC) for the quarter ending July 2011, Pfizer indicated that it has voluntarily provided the SEC and the Department of Justice (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.

FDA scientists published an article in the Aug. 4, 2011, issue of The New England Journal of Medicine that describes their current thinking about a pathway for the regulatory approval of biosimilars. The agency?s approach reflects its examination of EMA guidelines, as well as the nature of biological drugs.

In late July, FDA announced the 2012 user fees collected under the Prescription Drug User Fee Act (PDUFA) of 2007. The act stipulates that one-third of the PDUFA fee revenues FDA collects each year will be generated from each of three categories: applications for approval of drug and biological products, establishments where the products are made, and drug and biological products. In some instances, the fees can be waived, reduced, or refunded, as spelled out in an FDA draft guidance issued in March 2011.

The age of globalized industry should result in fewer barriers between countries, but it is rarely that straightforward in practice. At the India?US Strategic Dialogue held in New Dehli on July 19, 2011, India?s junior science minister Ashwani Kumar complained to US presidential science adviser John Holdren that a new US visa policy is hampering the ability of Indian scientists to travel to the United States, according to a report by ScienceInsider. Kumar asked that the procedure be streamlined. Indian scientists, even top aides to the government, are now required to renew their visa annually, but they previously could obtain a multiple-entry visa every 5 to 10 years. This change makes it difficult for Indian scientists to attend conferences in the US or engage in any other frequent, short-duration travel without attending to yearly paperwork. ?I understand the visa issue is a problem and a challenge, and we hope to improve it,? said Holdren, according to ScienceInsider.

The negotiations under way to control government spending and reduce the deficit have the potential to impact pharmaceutical revenues. A proposal is on the table to increase drug rebates under Medicare Part D as a means of controlling the overall costs of the Medicare program. The Pharmaceutical Research and Manufacturers of America (PhRMA) is opposed to such measures, concerned that a decrease in revenues could damage a healthy and growing industry and that the ripple-effects from a slowdown in biopharmaceutical growth could negatively impact an already fragile economy. In a press release, PhRMA president and CEO John J. Castellani issued the following statement:

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 (US) market.