FDA modifies REMS for two drugs to treat low platelet counts
SILVER SPRING, Md. — Prescribers, patients and specialty care centers no longer will be required to enroll in safety monitoring programs for two drugs used to treat low platelet counts, following changes to their risk evaluation and mitigation strategies.
The Food and Drug Administration announced changes to the REMS programs for Amgen’s Nplate (romiplostim) and GlaxoSmithKline’s Promacta (eltrombopag), two drugs approved in 2008 to treat low platelet counts in patients with chronic immune thrombocytopenia, who have not responded to other drugs or to the removal of their spleens. In addition, pharmacists will no longer have to enroll in the Promacta CARES safety monitoring program or verify prescriber and patient enrollment to dispense the drug. Meanwhile, both drugs’ REMS programs will include a communication plan to inform healthcare professionals about the changes and the drugs’ safety risks.
The FDA said that some of the requirements of the drugs’ REMS programs were no longer necessary to ensure that their benefits outweighed their risks.
"REMS continue to be vital tools for the agency to employ as we work with companies to address the serious risks associated with drugs and monitor their appropriate and safe use in various healthcare settings," FDA Center for Drug Evaluation and Research director Janet Woodcock said. "The agency remains committed to exercising a flexible and responsible regulatory approach that ensures REMS programs are being effectively and efficiently used and not resulting in an unnecessary burden on healthcare professionals and patients."
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Express Scripts, Medco grilled by Senate antitrust committee
WASHINGTON — George Paz, Express Scripts chairman and CEO, and David Snow, Medco Health Solutions chairman and CEO, were in a pair of hot seats Tuesday afternoon before the Senate Committee on the Judiciary Subcommittee on Antitrust, Competition Policy and Consumer Rights. Many of the questions posed by Senators on the subcommittee challenged the respective chief executives on how the proposed merger would negatively impact retail pharmacy and how the proposed merger would result in a dominant marketshare of the mail order pharmacy business.
According to marketshare figures cited by Sen. Richard Blumenthal, D-Conn., the Express Scripts/Medco merger would command 60% of the mail order business, versus 24% marketshare for CVS Caremark and 3% for the next largest mail-order operator. "The power I think is fearsome," he said. "Under the law it is problematic."
Michael Bettiga, EVP and COO of Shopko Stores and speaking on behalf of the National Association of Chain Drug Stores, stressed that the proposed merger would negatively impact patients by limiting or completely removing choice in how they receive their pharmacy services, as well as restrict patient access to services offered by highly-trained community pharmacists who provide education on medications and recommend lower-cost alternatives. Patients also could experience disjointed prescription medication records and stoppages to normal timely prescription service that could result in decreased medication adherence, or taking prescription medications as prescribed. "Here’s the reality," he told the Senate panel. "[The PBMs] can’t provide face-to-face content," he said. "At some point in time if accessibility is limited … what happens to that contact?"
"More consumers would be forced into using the PBMs’ own mail-order facilities. They will see decreased or limited access to essential pharmacy services,” Bettiga said in his prepared remarks. “Reducing patient choice and access will lead to higher prescription drug costs, potential adverse patient outcomes, and higher downstream health care costs.”
“If the FTC allows this merger, it will make an already bad situation even worse for small community pharmacies and the patients that we serve,” said Susan Sutter, co-owner of Marshland Pharmacies speaking on behalf of the National Community Pharmacists Association, in her prepared statements.
Regarding the potential impact the mega-merger would have on independent pharmacy, Paz said, "I can’t stop certain pharmacies from going out of business." Paz suggested that the U.S. market was oversaturated with retail pharmacy operations with 68,000 locations, versus about 10,000 McDonalds locations or 13,000 Starbucks locations. Paz then suggested Express Scripts would champion independent pharmacy. "My intention is to work a deal with the independent pharmacist and reimburse them at a higher rate than the [big-box pharmacies]," he said. "Our clients … are going to insist that we have that access to the [independent] pharmacist."
Sutter told the Senate panel that PBMs are unique in the sense that "they are part of our competition and [yet] they set our rates." "They put us on a very unfair playing field," she later added. "I would challenge [the PBMs] if they made it absolutely equal as to where their patient would go to, [community pharmacy would] win out."
In her prepared remarks, Sutter predicted “unparalleled market concentration in the PBM industry with the merged entity [will control] anywhere from one-third to two-thirds of all prescriptions filled in community pharmacies. This market dominance and significant reduction in competition will result in reduced choices for federal and state programs and third party payers, decreased patient access to pharmacy services and ultimately lead to higher prescription drug costs paid by plan sponsors and consumers.”
Sutter’s written testimony was accompanied by an economic estimate of the merger’s impact on Connecticut, Iowa, Minnesota, New York, Texas, Utah and Wisconsin (states represented by Senators on the subcommittee). The analysis was further supplemented with comments from community pharmacy owners in each of these states providing examples of their past experiences with these companies. In addition, accompanying the testimony were examples of alleged overshipping by various PBM mail order facilities, including Express Scripts and Medco, in a presentation entitled, “Waste Not, Want Not.”
“We have estimated that the merger, if approved, will cost the state of Wisconsin $68 million in sales and tax revenues annually and approximately 1,350 jobs and will send these precious resources to an out-of-state mail order pharmacy,” Sutter wrote. “The loss of pharmacies in rural communities could mean the end of primary health care for millions of individuals.”
Scott Streator, associate VP business development for the Ohio State University Medical Center and David Balto, senior fellow at the Center for American Progress and a prominent anti-trust attorney who is nationally known for his expertise in competition policy in a number of sectors, also testified Tuesday before the subcommittee.
To view Bettiga’s prepared testimony, click here.
To view Sutter’s prepared testimony, click here.
Click here for The New York Times story on the hearing published earlier today.
The proposal to release express scripts by the chairman of Medco Health Solutions had created confusion among dealers. They are protesting against this new decision. According to my opinion, by releasing express scripts consumers would be forced to use a company’s own mail-order facilities which will result in limited access to essential pharmacy services. Thanks for sharing this news.
would result in adominant marketshare of the mail order pharmacy business.negatively impact retail pharmacy and how the proposed merger
It's interesting that CVS is cutting pharmacist hours when they are getting thousands of ESI Rx transfers from Walgreens. It makes sence if every ESI Rx you fill is costing you money. Once again, pharmacy just rolls over and says, fine, I take whatever bone you throw me. Kudos for Walgreens. Shame on all the rest of the big chains who only care about selling an extra pak of gum.
Let's hold Express' Mr.Paz to his promise. Increase Independent Pharmacy's reimbursement NOW and then talk about the proposed merger in a year or two to see how things work out. Not going to happen.
Taro forms special committee to review Sun offer
HAIFA BAY, Israel — Israel’s Taro Pharmaceutical Industries has formed a special committee to review an offer by India’s Sun Pharmaceutical Industries for all of the shares of Taro that it doesn’t already own, Taro said.
Sun offered Taro $24.50 per share on Oct. 18. Sun has sought to acquire Taro since 2008.
Taro reported a 14.2% increase in sales in second quarter 2011 over second quarter 2010, while profits increased by $19.3 million during the same period.
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