Four members of Congress are seeking information around the pricing and costs related to two products that are more expensive versions of products previously available at a low cost.

The inquiry was opened in the form of May 24 letters from Senate Special Committee on Aging Chairman Herb Kohl, D-Wisc., and Reps. Henry Waxman, D-Calif., Frank Pallone, D-N.J., and Diana DeGette, D-Colo. to Avanir Pharmaceuticals CEO Keith Katkin regarding Nuedexta (quinidine sulfate and dextromethorphan hydrobromide) and URL Pharma, Inc. CEO Richard Roberts regarding Colcrys (colchicine).

Waxman, Pallone and DeGette all serve on the Energy and Commerce Committee, Waxman as ranking Democratic member, Pallone as the Health Subcommittee's ranking member, and Degette as the Oversight And Investigations Subcommittee's ranking member. Kohl, like the other three a frequent watchdog on drug pricing and competition, has announced he will not run for re-election in 2012.

The letters' charges about significant price increases for a new branded version of an inexpensive available drug echo the recent uproar over the price that KV Pharmaceuticals originally intended to charge for Makena (hydroxyprogesterone caproate), an FDA-approved version of a product previously only available from compounding pharmacists, but at a much lower price (Also see "Makena Pricing Prompts Multi-Pronged Appeals: FDA, FTC – Bayh-Dole?" - Pink Sheet, 21 March, 2011.). The issue drew interest from members of Congress, but the furor died down when FDA confirmed that patients would still have access to the compounded drug and KV agreed to drop its price (Also see "KV Cuts Makena Price 54%, Increases Medicaid Rebates, But Is It Enough?" - Pink Sheet, 4 April, 2011.).

The letter to Avanir maintains that quinidine and dextromethorphan are "generic drugs that have been available for decades and cost a fraction of Nuedexta," at $20 for a prescription, compared to the combination product at $600. FDA approved the combination in October 2010 to treat involuntary emotional incontinence (Also see "The Winning Combination: Avanir’s Nuedexta Finally Cleared For Emotional Incontinence" - Pink Sheet, 8 November, 2010.).

"Although we recognize that we all benefit when FDA approves a new, safe and effective formulation, it is not clear that the significantly higher prices charged for this drug are justified given that it is merely a combination of long-used and inexpensive generic medications," the letter says.

The letter to URL Pharma says the legislators have read reports that Colcrys prices are "unreasonable," since the price for unapproved versions that drug were formerly on the market was $0.09 per pill, but now the FDA-approved product costs $4.85.

The product was approved in 2009 to treat gout flares and familial Mediterranean fever, an orphan condition for which it received seven years of marketing exclusivity. There are safety reasons for FDA wanting an approved product on the market rather than unapproved versions, since the drug is subject to a Risk Evaluation and Mitigation Strategy; FDA ordered unapproved versions removed from the market (Also see "FDA Steps Into Makena Pricing Dispute In The Name Of "Access"" - Pink Sheet, 4 April, 2011.).

"Charging prices for newly-patented drugs 50 times higher than for the price of the same drugs that have been used for decades greatly increases costs for our nation's health care system," the letter says. It adds that doctors and patients are "understandably upset" about the pricing.

The letters ask each company to submit documentation in response to a list of questions, which are similar for each company.

Requested information include the cost of clinical trials needed for approval as well as the cost of any required post-marketing trials; correspondence with FDA related to the drug; how the product's price was established; how much has been spent and will be spent in the next year on marketing; anticipated revenues and profits; pricing and profit margin in foreign countries; and the company's patient assistance programs.

- Scott Steinke (s.steinke@elsevier.com)

Hill Democrats Continue Inquiries Into High Prices For New Versions Of Old Drugs; Avanir's Nuedexta And URL Pharma's Colcrys Targeted

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