Sepracor, Drug Cos. Fight Against Medicine Mixing
Compounding pharmacists say Congress,
Big Pharma threaten biz unnecessarily
Even though the Safe Drug Compounding Act of 2007 is dead, compounding pharmacists in Massachusetts say they expect the proposed legislation - which aims to curb the practice of drug customization - to come up again year after year as commercial drug companies seek to eliminate competition real and perceived.
The bill, which was proposed by U.S. Sens. Edward M. Kennedy, D-Mass., Pat Roberts, R-Kan. and Richard Burr, R-N.C., never even made it to the final version of the Prescription Drug User Fee Act that the U.S. Senate voted on in late September. But the effort was enough to prompt Sepracor Inc. of Marlborough to spend $20,000 to hire Washington, D.C., law firm Drinker Biddle & Reath to lobby in favor of it, according to documents filed with the U.S. Senate's Office of Public Records under the Lobbying Disclosure Act of 1995.
But reading the company's U.S. Security and Exchange Commission filings, one would think competition from compounding pharmacists would be the least of its worries.
In 2006, Sepracor was fighting with the FDA over the availability of cheaper, generic versions of Sepracor drugs. It was involved in patent litigation, class action lawsuits and SEC and IRS inquiries into the company's stock compensation plan.
The company does not include the cost of any litigation or inquiries in its last annual report, filed in March. "We are unable to reasonably estimate any possible range of loss or liability associated with the stock option inquiry and/or derivative suits due to their uncertain resolution," the company said of that particular matter. "We are unable to reasonably estimate any possible range of loss related to this lawsuit due to its uncertain resolution," it said of another.
True Apothecary
Concern from Sepracor and other drugmakers confounds Joseph Rossetti, whose family's Boulevard Pharmaceutical Compounding Center on Shrewsbury Street in Worcester has been compounding since 1931. He said the bill restricting compounding was "strictly a power play" by paranoid pharmaceutical companies that see competition where there isn't any.
Compounding is a broad term given to the customization of drugs for individual patients.
"There are a few pharmaceutical manufacturers that perceive compounded medicine as an alternative, and therefore competition, to their products, which isn't true," said Josh Wenderoff, a spokesman for the International Academy of Compounding Pharmacists. Patients that are allergic to inactive ingredients in "off-the-shelf" medications may seek to have custom medications made by compounding pharmacists, Wenderoff said.
Rossetti said, "Tons of doctors from UMass and all over the place call me every day. They have no place else to go" if, for example, they need a chemotherapy drug to be administered "in a different form."
"If we don't do a lot of this stuff, it won't be available at all," Rosetti said. Kennedy's bill "meant that for every prescription
we filled, we'd have to get a new application" to the U.S. Food and Drug Administration, making compounding essentially impossible for small pharmacies like his, Rosetti said.
Recommended Dose
"If regulation restricts compounding, it would force more patients to take off-the-shelf medications, which may not be optimal," Wenderoff said. "But (compounding) is a distinct market," he said. "I don't know what (pharmaceutical companies') cost benefit analysis" on paying for lobbyists to restrict compounding is, "but I would love to see it."
Sepracor's best-selling sleep drug Lunesta is one of two products the company credits with finally turning Sepracor a modest profit. But the sleep drug market is fiercely competitive, and Sepracor worries about Lunesta's ability to compete for any length of time.
Neither Rosetti nor Wenderoff would be surprised if some version of the safe compounding act came up again next year, regardless of how expensive it is for drug companies to lobby for. "They have nearly two lobbyists for every member of Congress," Wenderoff said. "I wouldn't be surprised if it came up."
Steve Bernardi, owner of Johnson Drug in Waltham, said legislation like the safe compounding act is fueled by confusion by large drug companies and the government.
He said congress also gets nervous about compounding when stories about athletes abusing HGH, human growth hormone, hit the news.
He said the state board of pharmacy does well enough in its regulation of pharmaceutical compounding.
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