Prescrition Drugs Imports from India

Imports From Indian Drug Maker Halted
By THE ASSOCIATED PRESS
WASHINGTON (AP) — The government blocked the importation of more than 30 generic drugs, including popular antibiotics and cholesterol medicines, made by India’s biggest pharmaceutical company, citing poor quality in two of its factories.

The Food and Drug Administration’s move does not end United States sales by the drug maker, Ranbaxy Laboratories. Instead, it blocks imports of generic drugs, including generic versions of the antibiotic Cipro and the cholesterol pill Zocor, as well as pharmaceutical ingredients made at the two suspect plants in India.

F.D.A. inspections this year found violations that could lead to contamination, allergic reactions and other problems, and the company has failed to take proper steps to correct them, said Deborah Autor, director of F.D.A.’s compliance office.

Also, the F.D.A. said it would not approve any new products for sale by Ranbaxy until the manufacturing violations are corrected.

The F.D.A. told consumers who have Ranbaxy products at home not to worry or quit using them: Repeated testing has not found any contaminated products, just the threat of them if factory conditions do not improve. Also, it would be hard for a patient to tell if drugs were made at the suspect factories or at one of Ranbaxy’s numerous other factories in 11 countries.

”We have seen no evidence of harm to consumers from drugs produced at these two facilities and have no reason to believe that drugs already in the U.S. from these plants pose a safety problem,” said F.D.A. deputy drug director Dr. Douglas Throckmorton.

The factories with defects are in Dewas and Paonta Sahib, India.

Lobbying on Prescription drugs

Novo Nordisk spent $350,000 lobbying in 2Q
Thursday August 28, 11:21 am ET
Drugmaker Novo Nordisk spent $350,000 lobbying government in second quarter


WASHINGTON (AP) -- Danish drugmaker Novo Nordisk AS spent $350,000 lobbying the U.S. government in the second quarter, according to a recent disclosure report.
The company lobbied on drug importation, patient safety protection, a bill to reduce health disparities, patent reform, diabetes patient care, and the Medicare Prescription Drug Price Negotiation Act, among other topics.

Novo Nordisk lobbied Congress, the Patent and Trademark Office, Department of Health and Human Services, Centers for Medicare and Medicaid Services, and the Office of Management and Budget.

Among those registered to lobby for Novo Nordisk in the April-June period was Lauren Semeniuk, who used to be legislative director for Rep. Cliff Stearns, R-Fla.

The company spent $330,000 lobbying on many of the same issues in the first quarter.