A Headache for Small Drug Makers
|A Headache for Small Drug Makers
By Peter Pitts
Larry Blansett, chief executive of the Blansett Pharmacal Company, sells a wide range of what he calls legacy drugs.
In the 1970s, Larry Blansett was producing a wide array of prescription cough syrups, antihistamine tablets and pain killers at the company he co-founded, UAD Laboratories. But the Food and Drug Administration was not keeping a close watch.
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Mr. Blansett continues to sell the same range of products at his latest venture, the Blansett Pharmacal Company, which employs about 90 people in North Little Rock, Ark. “We grew gradually at first, but are now a national company,” he said.
Now, however, the F.D.A. has begun to crack down on the thousands of drugs that have never had to go through the agency’s stringent approval process, many of them made by small companies like Blansett Pharmacal. And those companies are crying foul.
“The F.D.A. has never required these products to be regulated as new drugs,” Mr. Blansett said. “It has no regard for the cost or damage they do to small businesses. There are estimates that only a few of us will make it.”
The agency says it is only doing what it must do. “This is a public health initiative,” said Deborah A. Autor, director of the Office of Compliance at the F.D.A.’s Center of Drug Evaluation and Research. “Some of these drugs may not be safe. In all likelihood, these companies knew from Day 1 that they were producing illegal drugs.”
To counter the agency’s crackdown, a trade group representing about 50 small to medium-size companies has submitted a bill to Congress that would create a cheaper and simpler process for gaining F.D.A. approval. Mr. Blansett claimed the cost could run up to $5 million for a new drug application.
Perry Cole, executive director of the Branded Pharmaceutical Association, says several members of Congress have expressed support for the legislation. “I’m confident it will be introduced,” Mr. Cole said. He said these drugs — the makers call them legacy drugs and define them as drugs that have been prescribed for at least 25 years and have gained a history for safety and efficacy — were far safer than many prescription drugs of recent vintage, like Viagra, which he said had been associated with hundreds of premature deaths.
Peter Pitts, president of the nonprofit Center for Medicine in the Public Interest and a former F.D.A. associate commissioner, said the issue was complicated. “Many of these drugs were grandfathered in when the current approval process was instituted,” he said. “However, that doesn’t give these companies carte blanche — they still have to play by the rules.”
Sidney M. Wolfe, director of the Health Research Group at Public Citizen, a consumer advocacy group that he founded with Ralph Nader, takes a less benign view of the legacy drug makers, but he reserves his firepower for big pharmaceutical companies.
“The laws have to be enforced,” he said, but the F.D.A. “goes for the easy targets,” adding that “the collective harm all these small companies have done pales by comparison with just one or two unregulated products sold by bigger companies.”
“The F.D.A.’s priorities should be set according to the potential harm to the public,” Mr. Wolfe said. He contended that the agency had failed to act forcefully against big corporations because of their deep pockets and political clout and noted that these same corporations pay most of the cost of the drug reviews.
The agency began its campaign against the makers of unapproved drugs in June 2006, and immediately began ordering companies that made products that it deemed potentially hazardous to file new drug applications or take them off the market.
In December, for example, it told firms to stop making unapproved products containing quinine, which has been used since the 1600s to treat malaria. The one company that made an approved quinine product, Qualaquin, was the Mutual Pharmaceutical Company of Philadelphia, and the F.D.A’s action, in effect, granted Mutual a temporary monopoly.
In May, the agency ordered drug makers to stop selling unapproved forms of guaifenesin, an expectorant and cough suppressant.
Late last month, the agency said it would take enforcement action against companies that sold unapproved cough suppressants containing hydrocodone, a drug that dates back to the 1940s.
Ms. Autor, of the F.D.A., said only seven of more than 200 hydrocodone cough suppressants on the market had the agency’s approval. “One reason hydrocodone is a safety concern is because it is a narcotic, and in some cases has been labeled for use by children as young as 2,” she said.
Mr. Blansett said that his company produces two products containing guaifenesin and that he planned to stopping making both, at a cost of $2 million in annual sales. But, he added, he will do whatever he can to keep selling hydrocodone medications, which account for more than half his company’s annual revenue.
The F.D.A.’s demand that small drug makers file new drug applications was unrealistic, he said, because most could not afford the $5 million cost. “You won’t see any small companies out there anymore if the F.D.A. gets its way,” he said.
Ms. Autor acknowledged that the legal offensive poses difficult challenges for small drug makers, but she vowed to continue. “There are a few thousand unapproved drugs out there,” she said. “So far, the F.D.A. has taken action against approximately 500.”
The sale of unapproved drugs has been going on for so long “in part because companies have used the laws’ grandfather provisions as a cloak to cover illegal marketing,” Ms. Autor said. “The agency has been working on the unapproved drugs problem steadily through the years,” she said, but has “decided to tackle the issue once and for all.”
Drug makers, she said, had been put “on specific notice for at least four years that we intended to increase our emphasis on the issue.”
According to Mr. Blansett, small companies like his historically have been exempt from the rigorous trials that the F.D.A. requires for new drugs. Drugs like guaifenesin, which was used by Native Americans at least as far back as the 1500s, are aimed at relieving symptoms like sneezing, headaches and pain, not at curing disease, he said.
“Vioxx and other new drugs have to go through study after study with tests on 500 to 5,000 patients,” he said. “But legacy drugs have been used for many, many years on millions and millions of people.”
Ms. Autor said the agency did not recognize the term “legacy drugs.” Many had been introduced recently, she said, and many of their labels listed unapproved uses. She cited versions of carbinoxamine, an antihistamine also used for colds, that were labeled for use on children as young as one month and that have been associated with 21 infant deaths.
Mr. Blansett said he thought that the F.D.A. had exaggerated the adverse reactions of legacy drugs on children and said he would be happy to conform to any labeling changes the F.D.A. requested. “Why not just work with us?” he asked.
Mr. Pitts, of the Center for Medicine in the Public Interest, said he was sympathetic to Mr. Blansett’s appeal for the agency to work more closely with small drug makers. “The earlier you can get all parties to the table, including manufacturers, the better,” he said.
Some drugs singled out by the agency’s recent crackdown have already become much more expensive, according to the Branded Pharmaceutical Association. Mutual Pharmaceutial, for example, charges $385.13 for 100 Qualaquin tablets, each containing 324 milligrams of quinine sulfate, compared with $6 for 100 equivalent tablets that used to be available from other drug makers, the association said.
Mutual said the higher costs resulted from the “millions of dollars” it had spent to improve the safety of its quinine product.
In the meantime, the small drug makers and the F.D.A. remain at loggerheads. “Why is she doing this?” Mr. Blansett asked of the regulatory campaign. To which Ms. Autor replied, “It is not something that happened out of the blue.”
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