Debate in Congress over barriers to U.S. entry for a highly touted vaccine developed by a British company is sparking pushback from some prominent U.S. pharmaceutical leaders, as well as others.
Last week, Republican lawmakers including the chairman of the Senate Committee on Health, Education, Labor and Pensions asked Genentech, a unit of Swiss pharmaceutical giant Roche, for information on the vaccine technology, aimed at making it safer for patients.
The officials wanted to learn whether the vaccine would allow the United States to benefit from some of the manufacturer’s advantages.
“The action is anything but altruistic,” said Sen. Lamar Alexander, R-Tenn., chairman of the committee. “The stakes are high.”
He called it a “very innovative technology” that could “transform healthcare.”
Several committee Democrats joined the Republicans in their request, but they also have brought up concerns about barriers to the system. The National Institutes of Health, the Department of Health and Human Services, and the Food and Drug Administration are in charge of approving vaccines in the United States, which is why the technology is slow and expensive. In general, they argue, it requires work by foreign companies to assess whether a vaccine is safe for Americans.
Sally Pipes, the president of the conservative policy group the Atlas Center, said Congress should pass legislation that would block companies from bringing research to the United States without approval from the NIH and FDA, and she advocated requiring that all pharmaceutical products must be proven safe before they can be sold in the United States.
“Allowing for standards of due diligence on all new technologies should go hand in hand with our desire to see innovation brought to U.S. shores,” she said.
But the Council of Pharmaceutical Industries and Affiliates, a Washington-based trade group representing the pharmaceutical industry, has voiced its concerns in recent months, including after British scientists unveiled the new vaccine technology and the British government announced it would open up an initiative to make it available to vaccinate the British public.
The Council’s director, Andrew J. Bergman, said the group “strongly opposed” the establishment of a public effort to roll out the new vaccine, because it would preclude the use of a formula developed by the British company. The organization also has said that the ability to share protocols for the vaccine, if it does get approved for use in the United States, could improve its effectiveness.
The pharmaceutical company Pfizer, also based in Connecticut, has said it would not support a vaccine program that would make its costly marketing and production process essentially “the government’s problem.”
“Pfizer does not and should not support efforts by the U.S. government to do such,” a spokesman for the company said.
Some biotech companies say they still plan to provide this vaccine, which has been tested in primates for more than a decade, to the U.S. government, which has been discussing a public project.
David Levine, a spokesman for the U.S. National Institutes of Health, said an expanded public-private partnership that would allow open access to the vaccine has been one topic of discussion. The issue was raised at a roundtable last week with federal health and defense officials, he said.
“Discussions continue to explore the best strategies for access, including protecting intellectual property and transfer restrictions,” he said.
The National Institute of Allergy and Infectious Diseases has been studying the anthrax vaccine since 1999. Genentech is interested in entering the military-procurement process, hoping to expand its research into vaccines for other pathogens that pose a risk to Americans. The contract that Genentech was awarded with the British government has a deadline of May.