FDA investigates Ranbaxy factory in India
ROCKVILLE, Md. The Food and Drug Administration has taken new action against a plant owned by generic drug maker Ranbaxy that has been subject to an import alert since September, the agency announced Wednesday.
The FDA said that Ranbaxy’s factory in Paonta Sahib, India, falsified data and test results in approved and pending drug approval applications. The agency said it has not found evidence that the drugs to not meet quality standards and has not found risks to public health associated with currently marketed Ranbaxy products.
“Companies must provide truthful and accurate information in their marketing applications,” FDA Center for Drug Evaluation and Research director Janet Woodcock said in a statement. “The American public expects and deserves no less.”
The FDA has invoked its Application Integrity Policy against the Paonta Sahib plant. Under the AIP, the agency has asked Ranbaxy to cooperate in resolving the issue of data integrity and reliability, including implementing a Corrective Action Operating Plan to provide assurance of the integrity and reliability of data from the plant. The agency has also stopped all substantive scientific review of drug approval applications from data originating at the Paonta Sahib plant.
“The FDA’s investigations revealed a pattern of questionable data raising significant questions regarding the reliability of certain applications, and this warrants applying the Application Integrity Policy,” CDER Office of Compliance director Deborah Autor said in a statement. “Today’s action the FDA’s continued vigilance and its steadfast commitment to safeguarding the public’s health.”
The FDA barred the entry of finished drug products and active pharmaceutical ingredients from Ranbaxy’s plants in Paonta Sahib, Dewas and Batamandi Unit when it found they had violated the agency’s current Good Manufacturing Practices requirements. The action remains in effect and bans the importation of 30 generic drugs from the plants.
Heart drug Efient approved by EMEA
INDIANAPOLIS The European Medicines Agency has approved a new drug by Eli Lilly & Co. and partner Daiichi Sankyo Co. for preventing heart attacks in patients with acute coronary syndrome undergoing a heart-opening procedure, the two companies announced Monday.
The EMEA approved Efient (prasugrel) for ACS patients undergoing percutaneous coronary intervention surgery following a positive opinion adopted by the EMEA’s Committee for Medicinal Products for Human Use.
“This European approval is good news for doctors and patients since more than 700,000 people die from heart attacks in the European Union each year,” Daiichi Sankyo president and CEO Takashi Shoda said in a statement. “We believe Efient will become an important new treatment for patients with ACS undergoing PCI, a severe disease with potentially life-threatening consequences.”
The Food and Drug Administration’s Cardiovascular and Renal Drugs Advisory Committee voted unanimously to recommend approval of prasugrel for the United States market on Feb. 3, but the two companies had not decided on a brand name at the time.
Health care to continue growing as share of economy says new CMS report
WASHINGTON Growth in healthcare spending probably will decline by this year because of the recession, but health will continue growing as a share of the economy, according to a new report by the Centers for Medicare and Medicaid Services.
Growth in national health expenditures is expected to be 6.1% in 2008, as it increases from $2.2 trillion in 2007 to $2.4 trillion in 2008, while growth in the gross domestic product is expected to be 3.5%. For this year, healthcare spending is expected to increase by 5.5%, while the GDP is expected to decline by 0.2%. Meanwhile, the health share of the GDP is expected to increase from 16.2% in 2007 to 16.6% in 2008 and 17.6% in 2009, representing about one-third of the total increase in the health share of the GDP for 2008 through 2018.
Prescription drug spending growth is expected to slow from 4.9% in 2007 to 3.5% in 2008, as customers fill fewer prescriptions and switch to generics, but prescription drug spending growth likely will rebound to 4% in 2009.