News article calls Mylan’s quality control into question; company responds
PITTSBURGH A news article published over the weekend calling generic drug maker Mylan’s manufacturing into question has drawn a response from the company.
The Pittsburgh Post-Gazette reported Sunday that workers at the company’s Morgantown, W.Va., plant overrode drug quality controls required by the government by ignoring and deleting computer warnings of possible drug quality or equipment problems, based on a confidential internal report obtained by the newspaper’s reporters that called it a “pervasive” problem. Normally the warnings, known as “red screens,” require production to halt until a quality-control agent can investigate the matter.
The company responded by saying in a statement Monday that the Post-Gazette article was based on anonymous sources, improperly obtained documents and third-party commentary.
“Our customers and stakeholders can rest assured that whenever there is even the slightest departure from [a standard operating procedure], it will be dealt with immediately and effectively,” the company said in a statement. “This issue had no impact on the quality of our product.”
NACDS urges House to improve Part D, control prescription drug expenditures in healthcare reform legislation
ALEXANDRIA, Va. Retail pharmacy chains hope to see changes to Medicare Part D and assistance in controlling prescription drug expenditures included in the America’s Affordable Health Choices Act of 2009, according to a letter delivered to members of the House this week.
In the letter – written to House Ways and Means Committee chairman Chuck Rangel, D-N.Y., House Energy and Commerce Committee chairman Henry Waxman, D-Calif., and the committees’ ranking Republicans – National Association of Chain Drug Stores president Steven Anderson praised sections of the bill designed to cover the Medicare Part D coverage gap. The gap, also called the doughnut hole, causes seniors to lose Part D coverage when their annual prescription drug expenditures are between $2,700 and $6,154.
Anderson urged policies including a clarification of language ensuring that pharmacies would not be expected to cover the discounted portion of the price of a drug covered under Part D; expansion of extended days’ supplies of drugs – such as 90-day supplies – as a way to reduce dispensing fees and copays; and a rolling Part D enrollment period to alleviate disruptions in care that he said resulted from current enrollment rules.
Teva settles patent suit with Ortho-McNeil-Janssen
JERUSALEM Teva Pharmaceutical Industries has announced its settlement of its patent infringement lawsuit over its generic version of a popular contraceptive.
Teva said it has entered into a definitive agreement with Ortho-McNeil-Janssen to settle the suit in the U.S. District Court for the District of New Jersey related to Teva’s generic Ortho Tri-Cyclen Lo. Under the terms of the settlement, Teva will obtain a release for past sales of its generic product, in exchange for an undisclosed royalty payment. Teva also will obtain a license to re-enter the market on December 31, 2015, or earlier in certain circumstances.
The settlement will not become effective until the court enters a proposed consent judgment upholding the validity and enforceability of Ortho’s patent.