Perrigo seeks approval for generic Zegerid OTC, Schering-Plough files suit
ALLEGAN, Mich. Perrigo has filed for regulatory approval of a generic version of an over-the-counter medication for frequent heartburn, prompting a lawsuit from the branded version’s manufacturer.
The company announced Friday that it had filed for approval for omeprazole and sodium bicarbonate in the 20 mg/1,100 mg strength. The medication is a generic version of Zegerid OTC, made by Schering-Plough HealthCare, a subsidiary of Merck.
Schering-Plough filed a lawsuit Monday alleging patent infringement in the U.S. District Court for the District of New Jersey to prevent Perrigo’s commercialization of the product.
Zegerid had sales of around $60 million during the 12-month period ended in the “most recent month,” according to SymphonyIRI Group.
NBTY shareholders OK adopting merger agreement
RONKONKOMA, N.Y. NBTY on Wednesday announced that its stockholders have approved the proposal to adopt the merger agreement providing for NBTY’s acquisition by an affiliate of The Carlyle Group.
The affirmative vote of the holders of a majority of the outstanding shares of common stock of NBTY was required to approve the proposal to adopt the merger agreement. According to the final tally of shares voted, approximately 50.5 million shares of common stock of NBTY voted for the approval of the proposal to adopt the merger agreement, representing approximately 79.6% of the outstanding shares of common stock of NBTY as of the close of business on Aug. 23, the record date for this vote.
Following the approval of the proposal to adopt the merger agreement by NBTY’s stockholders, all conditions to the closing of the merger set forth in the merger agreement have been satisfied (other than those conditions to be satisfied by action taken by the parties at the closing). Under the merger agreement, the affiliate of Carlyle is obligated to consummate the merger upon completion of the 20-day marketing period for the debt financing, which will commence on Sept. 23, but it is NBTY’s expectation that the merger could be completed as soon as the beginning of October.
Efforts to combat Medicare fraud draw mixed signals from indies, PBMs
WASHINGTON The independent pharmacy and pharmacy benefit management industries both praised new efforts by Congress and the Obama administration to end the fraudulent and abusive billing practices that plague Medicare and Medicaid and cost U.S. taxpayers tens of billions of dollars. But their recommendations for combating the problem are as different as their approaches to the pharmaceutical market.
The Centers for Medicare & Medicaid Services proposed new regulations to help prevent what the agency said is $55 billion in annual improper payments to providers and health plans. In a related development, the House Energy and Commerce Subcommittee on Health is looking at ways to attack the problem, and held a hearing Thursday titled, “Cutting Fraud, Waste and Abuse in Medicare and Medicaid.”
The National Community Pharmacists Association weighed in with a statement to the House panel that accused the pharmacy benefit management industry of responsibility for much of the abuse, which the group attributed to a “past record of alleged systematic chicanery.”
In its statement, the independent pharmacy lobby reminded lawmakers of numerous allegations of fraud by major PBMs, as well as “misrepresentation to plans, patients and providers; improper therapeutic solutions; unjust enrichment through secret kickback schemes; and failure to meet ethical and safety standards.” The group urged Congress to pass legislation “to rein in the waste being generated by the business practices of pharmacy benefit managers under Medicare and Medicaid,” and to increase the transparency of PBM audit practices.
Not surprisingly, the response from the Pharmaceutical Care Management Association, the main PBM industry advocacy group, was markedly different. Responding to new proposed regulations from CMS to combat fraud and abuse, PCMA president and CEO Mark Merritt said the government’s focus should be on preventing abuse rather than on pursuing wrongdoers after the fact for fraudulent billing practices. “Pharmacy benefit managers agree that prevention, not ‘pay and chase,’ is the key to fighting fraud,” Merritt noted. “Unfortunately, some public policies undermine the fight against fraud by requiring payers to include pharmacies in their networks that have been banned from federal programs.”
Merritt also reiterated PCMA’s call for legislation to eliminate legislative “prompt-pay” requirements that force pharmacy benefit plans to quickly pay prescription claims, raising again a major source of friction between the PBM and retail pharmacy industries. Policies that require payers to “accelerate payments,” PCMA’s leader charged, leave “less time to detect and prevent fraudulent Medicare claims before payments are made.”