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By GOLDIE BLUMENSTYK
The Chronicle of Higher Education
Two groups that represent tens of thousands of students involved in medical research are taking the Association of American Universities to task for its “unconscionable” endorsement of a proposed federal law that would guarantee drug companies 12 years of exclusivity to sell certain kinds of drugs and vaccines they develop.
The groups say the association’s position on so-called follow-on biologics, or “biosimilars,” puts the universities’ profit motives ahead of the needs of the public.
The measure will “dramatically restrict access to affordable medicines and likely cost consumers and the federal government billions of dollars,” say the American Medical Student Association and Universities Allied for Essential Medicines, in a letter to the AAU. A third organization, a consumer group called Essential Action, also signed onto the letter.
The proposed law is now the focus of intense lobbying here, pro and con, from an array of interest groups, including AARP (which opposes a long period of exclusivity for fear that it will raise medical costs) and the Biotechnology Industry Organization (which favors it, saying it will encourage companies to invest in innovation).
The student groups and other opponents of the measure fear that if the proposed law is added to health-care-reform legislation now moving through the U.S. House of Representatives, it will be hard to stop. The House may take up the bill as early as this week. The 12-years-of-exclusivity measure is already included in the Senate’s version of a health-care-reform bill.
The AAU, which represents more than 60 top research universities, says it supports the measure because commercial drug companies need assurance that it will be worth it to them to invest in the high-risk business of making the new biologic drugs from inventions coming out of university laboratories. The exclusivity provision is designed to let them recover the costs of their investments before copycat versions of the drugs are allowed onto the market.
Dealing With Copycats
“This is a very new field with dramatic possibilities, and we would like to see it work,” said John C. Vaughn, executive vice president of the association. In practice, he added, the exclusivity provided for in the proposed law would not be all that different from what is currently allowed for “small molecule” drugs.
Biologics, which are based on proteins, are more complex in structure and more difficult to make than small-molecule drugs.
Biologics are also harder to protect with patents because drug developers, by tweaking just a few protein strains, can design around the patented idea and create an imitation drug that does the same thing as the original.
Under current federal rules for generic small-molecule drugs, which are literally copies of the first drug, the nonbranded versions can come onto the market within five years of the original, although the existence of a patent on the drug often delays that further. After five years, generic manufacturers can ask the Food and Drug Administration for approval to make a copycat product based on the same safety and efficacy data submitted by the original drug maker.
Because patents won’t be as effective in protecting exclusivity against biosimilars, the pharmaceutical and biotechnology industries asked Congress to establish a longer period of data exclusivity for biologics—they originally sought 14 years, based on reports from some economists—before generic makers could use data provided to the FDA from the creator of the product. In June the Obama administration, which is counting on lower-cost generics as a keystone to health reform, said seven years would be a “generous compromise.”
Ethan Guillén, executive director of the Universities Allied group, said the organizations recognized the need for some period of data exclusivity but believed 12 years was too long. “Universities must take evidence-based stances that benefit society, and not simply act as echo chambers for PhRMA and BIO priorities,” the groups wrote in the letter, referring to the chief lobbyists for pharmaceutical and biotechnology companies.
Mr. Vaughn said that the AAU’s position was based on market assessments it found reliable, and that the association had sought a balanced position that would take into account the market realities of the pharmaceutical industry and the needs of the public.
Although many influential parties are playing a role in the debate, Mr. Guillén said the AAU’s withdrawal of support for 12 years of exclusivity could still be significant, both for its symbolism and because it would “remove a fig leaf” that now gives the pharmaceutical industry and others cover to support that many years to monopolize the market.
His group, which has also been working with the AAU and other academic organizations to direct more university research toward improving human health in the developing world, said the association’s position seems to contradict its stance urging universities to be more focused on public health in their licensing practices.
Universities Allied is a coalition of students at more than 40 research institutions in the United States, Canada, and Europe. The medical-student association represents more than 62,000 members, including medical and premedical students, residents, and practicing physicians.