"The Affordable Biologics for Consumers Act of 2007", S. 1505, and the "Patient Protection and Innovative Biologic Medicines Act", H.R. 1956, both would develop a safe and effective process for the approval of follow-on versions of revolutionary biologic medicines. These two bills create pathways for less expensive versions of biologic drugs that maintain the current high patient safety and scientific standards.
Currently, patients can rely on the fact that any generic drug they take is the "same" as the brand name product, which has already been proven safe and effective. The "Patient Protection and Innovative Biologic Medicines Act," sponsored by Representatives Jay Inslee (D-WA), Gene Green (D-TX) and Tammy Baldwin (D-WI), and "The Affordable Biologics for Consumers Act of 2007," sponsored by Senators Judd Gregg (R-NH), Richard Burr (R-NC) and Tom Coburn (R-OK), both reflect the unique nature of ground-breaking biologic drugs and ensure that patients are not subjected to unproven and potentially unsafe products.
Specifically, H.R. 1956 and S. 1505 would:
- Maintain the high standard of FDA approvals. H.R. 1956 and S. 1505 don't sacrifice patient safety in the pursuit of lower cost drugs. The bills insist that follow-on versions of biologics must be proven as safe, pure and potent as the original innovator drug. [not a big deal anymore].
- Acknowledge the scientific differences between biologics and traditional drugs. Biologics are much more complex than traditional pill products since they are created from living cells as opposed to a chemical reaction. As a result, the data collected to prove a biologic safe and effective is unique and applicable only to that product and not to a generic replication of a similar product. Both of these bills understand the complex nature of manufacturing drugs from living cells, and develop instead a process for approval that is tailored to the unique demands of these lifesaving medicines.
- Empowers the FDA to conduct post-marketing safety studies. Both bills would allow the FDA to require follow-on biologic product applicants to conduct post-marketing clinical trials or studies and include a plan for post-marketing safety monitoring. These two bills understand the inherent differences between biologic products and their follow-on versions. Subsequently, they ensure that a rigorous oversight process is in place to ensure that these unique copies with their own unique properties are safe for patient use.
- Maintain the standard for "interchangeablility." Under current law, the FDA advises patients that brand name drugs and generic copies are interchangeable if they have the same active ingredient, same dosage and identical strengths or concentrations. Due to the complex nature of manufacturing biologics, such guarantees cannot be made. Both H.R. 1956 and S. 1505 prohibit the FDA from designating a similar biological product as interchangeable or substitutable for the reference product, thereby leaving such decisions to treating physicians.
- Preserves incentives for innovation. Both bills would provide fourteen years of data protection to ensure innovators are motivated to make the risky investments necessary to discover new treatments and cures. The Gregg/Burr/Coburn legislation also includes the establishment of patent notification requirements to ensure that intellectual property rights of all patent holders are protected.