PHARMACY

Merck opts to settle suits with $650 million payout

BY Drew Buono

WHITEHOUSE STATION, N.J. Merck will pay more than $650 million to settle a variety of lawsuits related to past sales and marketing practices, according to The Wall Street Journal.

The major issue involved is a practice known as “nominal pricing,” which has appeared in a lawsuit filed by a former Merck employee and joined by the Justice Department and all states except Arizona. The settlement allocates $218 million to the federal government and $181 million to 49 states and the District of Columbia.

Merck also said it is paying $250 million to resolve a suit involving pricing of its heartburn drug Pepcid, filed in Louisiana by a local doctor and joined by the Justice Department and the same 49 states. In all, the company agreed to pay $649 million plus interest.

The nominal-pricing lawsuit concerns discounts on drugs supposedly offered to certain customers but not to Medicaid. The suit alleged Merck offered discounts of 90 percent or more on the cholesterol pills Zocor and Mevacor and the now-withdrawn painkiller Vioxx to hospitals that helped Merck achieve market-share goals, and that it improperly gave doctors incentives to use the products.

Federal law requires drug makers to give Medicaid the best price they offer any customer. But an exception says medicines sold at discounts of 90 percent or more don’t have to be disclosed or included in the best-price calculation. That steep discount was meant to let companies make inexpensive medicines available to charitable organizations.

The law doesn’t specifically say who can receive the special pricing. But regulators alleged Merck’s pricing for the hospitals didn’t qualify, because it came in exchange for their agreeing to sell certain volumes of Merck’s drug, at the expense of rival medications.

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PHARMACY

HealthPort receives SureScripts’ certified approval

BY Drew Buono

COLUMBIA, S.C. HealthPort’s Electronic Medical Record application is now certified to connect to The Pharmacy Health Information Exchange operated by SureScripts.

HealthPort’s e-prescribing module replaces old error-prone approaches to prescribing such as handwritten prescriptions, computer-printed prescriptions, and computer-faxed prescriptions. It also reduces the risk of medication errors associated with poor handwriting, illegible faxes, similar sounding/named drugs, and manual data entry.

As a SureScripts Certified Solution Provider, HealthPort’s physician clients who use its electronic medical record product can now connect to the Pharmacy Health Information Exchange, operated by SureScripts. The Pharmacy Health Information Exchange allows physicians and pharmacists to electronically exchange prescription information and electronically transmit new prescriptions and refill requests during routine and emergency care.

Today, more than 95 percent of all pharmacies are certified on the Pharmacy Health Information Exchange and approximately two-thirds are processing prescriptions electronically.

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FDA is not ready to pursue authority to approve follow-on biologics

BY Drew Buono

WASHINGTON Food and Drug Administration spokesperson Christopher Kelly recently said that, despite comments from an agency official on Monday, the agency will not submit to Congress a legislative proposal to seek authority to approve generic versions of biotechnology medications, CongressDaily reports.

FDA chief operating officer John Dyer had said on Monday that the agency had begun to draft language for such a proposal. In addition, a congressional aide said that the FDA informed the House Energy and Commerce Committee about plans to submit such a proposal but did not disclose a timeline.

Kelly said that the comments from Dyer resulted from a misunderstanding. Fiscal year 2009 budget documents refer to a legislative proposal that will provide recommendations on an FDA approval process for generic versions of biotech medications. Kelly said that the reference to such a proposal was an “expression by FDA of our interest in moving this forward, not an actual proposal.”

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