excerpt from WSJ article on Schering---<<Schering-Plough applied in October 1999 for permission to sell this successor drug, expecting approval within a year. But its relations with the FDA frayed seriously, delaying approval. FDA inspectors determined that the company's manufacturing plants in New Jersey and Puerto Rico weren't following proper procedures. Among the most worrisome findings: Schering-Plough was sometimes shipping asthma inhalers -- a critical aid for asthmatics -- without any medicine inside. For years, Schering-Plough recalled suspect asthma inhalers; for years, the FDA warned the company to clean up its act; for years, executives promised reforms.
In January 2000, a top executive said Schering-Plough had resolved all the FDA's manufacturing issues. It hadn't. More than a year later, the company disclosed that regulators were refusing to approve Clarinex until it fixed its manufacturing problems.
The company promised to hire hundreds of quality-control employees and spend millions in manufacturing improvements. Three months ago, it simultaneously announced two things: The FDA was levying a fine over the manufacturing mishaps, which still hasn't been determined but might be as much as $500 million; and Clarinex at last had marketing approval. Sales began in January.
The delay left the company less than a year to persuade its legions of Claritin users to start using Clarinex instead. Drug companies usually need years to switch loyal users of a drug over to a follow-on product. When Bristol-Myers Squibb Co.'s Glucophage diabetes medicine faced generic competition, the maker had 15 months to try to switch patients to two successor versions. Even though these were more convenient, it managed to convert only about a third of the patients.
Switching Markets
The other blow to Schering-Plough's allergy franchise was totally unexpected. An FDA advisory committee began considering whether to switch Claritin and similar nonsedating antihistamines, such as Aventis SA's Allegra and Pfizer Inc.'s Zyrtec, to nonprescription status. Such switches normally result from requests by the drugs' makers. In this case, the makers were staunchly opposed to the switch. The impetus came from a managed-care group, Wellpoint Health Networks, which is out to curb the cost of treating allergies.>> online.wsj.com link to full article(is a pay site) |
