The US Spends How Much On Unapproved Drugs?

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hawthorn-pharmaThis is a question the US Senate Finance Committee is trying to answer as part of an investigation into Medicaid drug reimbursements. A letter was recently sent to Hawthorn Pharmaceuticals to ask about allegations the little-known drugmaker has been receiving improper government payments for its drugs, including Dytan, a cough-and-cold med.

The inquiry comes as the committee tries to determine how and why retroactive changes were made to the database used for Medicaid reimbursement for Dytan and other drugs, such as Avandia and Vytorin. The committee also wrote Kerry Weems, who heads the Center for Medicare and Medicaid Services, to find out who maintains and updates the database, and whether reimbursement decisions were affected by the changes. (This is the letter).

According to the committee, Dytan has was never reviewed by the FDA, but made it to Medicaid’s reimbursement program. Look at the chart in the letter to the CMS - the original data for the first quarter of 2006 showed the government spent more than $58 million on reimbursements for 353,000 Dytan scrips. After April, the database shows $99,000 spent on 3,500 scrips in the same time period. We rang Hawthorn ceo Max Draughn, but he has yet to respond.

Another drug drawing scrutiny is Glaxo’s Avandia diabetes pill. In December, the database shows more than $98 million was paid to reimburse states for 1 million-plus scrips during the third quarter of 2006. But the altered datbase indicates $4.4 million was spent to reimburse only 33,500 scrips.

Yet another example is Vytorin, the controversial cholesterol pill sold by Merck and Schering-Plough. The database showed nearly $19 million in payments for more than 700,000 scrips in the third quarter of 2006. But in April, payments amouted to $1.3 millio for 14,500 scrips.

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