PHARMACY

Eli Lilly takes a stand against drug import legislation

BY Drew Buono

INDIANAPOLIS Eli Lilly is preparing to fight new legislation that would allow Americans to import lower-priced prescription drugs from other countries, saying it would put consumers at huge risk of dangerous counterfeit medicines, which it says is growing to epidemic proportions, according to the Indianapolis Star.

Eli Lilly and other U.S. drug makers won a similar battle last year when the Senate killed a drive that would have allowed consumers, pharmacists, drug wholesalers and distributors to import drugs from Canada, Japan, Australia and many European countries.

But what the drug industry sees as a threat to patient safety and its intellectual property, some consumer groups say is a needed way to provide lower-cost drugs to Americans, who pay the highest prices in the world for prescription medicines. Supporters say the bill adequately protects the public against counterfeit drugs.

The companies though are very concerned about counterfeit drugs being brought into the country. They feel the drugs are unsafe and pose a real health threat and on top of which it would be hard to monitor the countries exporting the medications. Organized criminals, the industry says, make many of the drugs, in unsanitary conditions that would never pass FDA approval. Lawmakers though argue that the bill would have provisions in it to allow the Food and Drug Administration to inspect the warehouses of foreign exporters and domestic importers.

The bill has yet to be set for a vote, and both sides say it could come up with little notice.

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Ranbaxy, GSK settle over Imitrex litigation

BY Drew Buono

HARYANA, India Ranbaxy Laboratories has settled litigation with GlaxoSmithKline related to sumatriptan succinate tablets, the generic of GlaxoSmithKline’s drug Imitrex, according to published reports.

The settlement will allow Ranbaxy to exclusively sell the generic for 180 days starting December this year. Under the terms of the settlement, Ranbaxy can distribute a generic version of sumatriptan in 25 mg, 50 mg and 100 mg doses.

Analysts expect the company to make around $100 million in sumatriptan sales in the U.S. during the exclusivity period. Sumatriptan sales in the U.S. are worth $985 million, according to IMS data.

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FDA delays Kynapid decision pending final review

BY Drew Buono

VANCOUVER, Canada The Food and Drug Administration has delayed its decision on an application for the heart treatment drug Kynapid, according to published reports. The drug manufacturer Cardiome Pharma and its co-development partner Astellas Pharma US said yesterday that the FDA did not provide an action letter by the expected date of Jan. 19.

The application for Kynapid (vernakalant hydrochloride), based on a five-year clinical development program, was submitted in December 2006. In December 2007, the FDA’s cardiovascular and renal drugs advisory committee voted 6-2 in favor of recommending to the FDA that Kynapid be approved for the rapid conversion of acute atrial fibrillation to sinus rhythm.

“While we look forward to the FDA reaching a decision, we respect their need for additional time to review the Kynapid’s application,” said William Fitzsimmons, senior vice-president for research and development at Astellas.

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