In response to conservative criticisms that a new biosimilars law doesn't go far enough to ensure the safety of those drugs, the sponsor of the provision, Rep. Anna Eshoo (D-Calif.), defended her creation this week, arguing that safety precautions are better left in the hands of federal regulators than the pharmaceutical companies.
The Democrats' new healthcare reform law empowered the Food and Drug Administration (FDA) to approve next-generation biopharmaceuticals based, in part, on the safety and efficacy record of the original breakthrough drug. The provision, championed also by the late-Sen. Edward Kennedy (D-Mass.), was designed to get biosimilars — and the cost savings that accompany them — to the marketplace more quickly.
But critics worry that the law leaves FDA with too much leeway to approve those drugs — including the flexibility to decide whether clinical trials are necessary at all. Some are pushing for such trials to accompany all new biosimilars.
Eshoo says the criticisms are unmerited.
"The FDA has both the responsibility and the expertise to determine a drug’s safety and efficacy — not drug companies, insurance companies, or members of Congress," the California Democrat said in an e-mail. "As technology evolves, the FDA must have the flexibility to determine the most effective ways to test biologics."
Her legislation, Eshoo added, "requires the FDA to use its expertise to conduct clinical trials for every biosimilar unless the safety, purity, and potency can be demonstrated with certainty."
"The patient protections included in the legislation are the strongest of any considered in Congress and received the broad support of dozens of medical and patient organizations, including the Alliance for Patient Access, the InterAmerican College of Physicians and Surgeons, and RetireSafe."
The Eshoo provision was co-sponsored by Rep. Joe Barton (R-Texas).