In a letter sent today, Rep. Henry Waxman (D-Calif.), chairman of the House Energy and Commerce Committee, urged President Barack Obama to consider whether the Food and Drug Administration can use its existing authority to begin clearing the way for the approval of generic versions of biologic drugs.
If possible, the action would jump-start a push by some lawmakers and the Obama administration to create a cost-effective alternative to expensive biologic drugs, which are estimated to cost Americans more than $40 billion annually. The FDA currently has no authority to approve generic copies of biologics, which are created from living cells. Under current law, a manufacturer who proposes making a generic version of an off-patent biologic drug must run costly clinical trials to prove that its cell line is as effective and safe as the one used by the original drugmaker.
In March, Waxman introduced the Promoting Innovation and Access to Life-Saving Medicines Acta bill that would give the FDA the power to approve bio-generic versions of such drugs. When this legislation passes, it is important for the FDA to begin implementing the program as soon as possible, wrote Waxman in the letter. He urged the president to prompt the agency to begin preparing for its anticipated new authority.
Waxman also asked the Obama administration for an analysis of the long-term savings that could be generated from bio-generic versions of biologic drugs.