HHS reclaims authority to investigate FDA employees
WASHINGTON According to a letter from House lawmakers, the department of Health and Human Services is reclaiming the authority to investigate potential ethical and criminal violations among Food and Drug Administration employees.
HHS is revoking a letter of understanding that gave the FDA’s Office of Internal Affairs the jurisdiction to investigate possible violations, including conflicts of interest, by FDA employees. HHS’ Office of Inspector General will now handle the investigations, as stated in a letter from House Energy and Commerce Committee lawmakers.
The committee, which has been investigating ethics violations at HHS and the FDA, approved of the decision. Allowing FDA employees to investigate other agency employees was “improper and a violation of the intent of the inspector general statutory purpose,” the letter to HHS inspector general Daniel Levinson said.
Orphan drug application process to ease in U.S., Europe
WASHINGTON & LONDON The Food and Drug Administration, European Commission and European Medicines Agency have decided to ease the application process for orphan drugs, drugs that are necessary but would be expensive and unprofitable to develop, in a move aimed at increasing the development of treatments for rare diseases, according to Reuters.
The agencies have adopted a common application, which would allow drug companies to apply to both regions at the same time with one application.
Rare diseases are defined as those affecting fewer than five in 10,000 people in the European Union and fewer than 200,000 people in the United States. About 30 million people in the European Union and about 25 million Americans suffer from more than 6,000 rare diseases.
India’s drug makers move beyond generics
NEW DELHI, India
India’s big pharmaceutical companies are moving from generic drug manufacturing to introducing their own originally researched drug molecules, which are expected to hit the market by 2010-11, according to published reports.
Among the companies involved in research and development of the new molecules are Ranbaxy, Glenmark and Dr. Reddy’s. Altogether about 10 to 12 companies have molecules under various stages of development.
Research and development investments now account for as much as 7 percent to 9 percent of sales. For example, Ranbaxy invested $80 million in research and development in 2006-07; this year that number has gone up to $100 million.
The key for these companies will be to partner with more experienced pharmaceutical manufacturers to help conduct more original research and development on new drugs.