In 2010, the President of the United States signed the Patient Protection and Affordable Care Act, thereby making it law. This Act contains the Biologics Price Competition and Innovation Act of 2009 (this act is abbreviated as BPCI Act), which is similar to a previous law called the Drug Price Competition and Patent Term Restoration Act of 1984. As is policy, a public hearing was held by the U.S. Food and Drug Administration (FDA) on November 2-3, 2010 in order to elicit information from the public regarding implementation of the BPCI Act.
The reason for this meeting was to receive input from:
??? current drug application holders (and prospective biological license applicants)
??? health care institutes
??? health care professionals
??? manufacturers of biomedical products (for example, pharmaceutical products, drugs, etc.)
??? patients
??? patient associations
??? professional associations (for example, scientific societies)
??? third-party payers (for example, health insurance companies)
What the BPCI Act intends to do is to shorten the pathway a drug undergoes in order to be granted approval by the FDA. The biological products that would fall under this category of regulation are drugs that have been demonstrated to be biosimilar to a current biological product (for example, a drug) already approved by the FDA, or established to be interchangeable with a drug that has also been approved by the FDA.
The BPCI Act is in keeping with current policy and procedure with the FDA, and the thought behind the BPCI is that it would save time and, perhaps, save resources that would be expended towards establishing the safety and efficacy of these ???new??? products. An additional issue that the BPCI Act would address is the unnecessary duplication that would occur if these ???new??? products had to undergo full testing ??? testing that would include various stages of both animal experiments and human testing.
Following the hearing, companies like PharmaNet issued reports containing their thoughts on the BPCI Act. In general, there is support for the Act and the time and money it will save, but concerns still loom.
