The "Access to Life-Saving Medicine Act", H.R. 1038 or the Waxman-Schumer-Clinton bill, permits approval of prescription drugs that have not been tested and threatens patient safety.
Sponsored by Rep. Henry Waxman (D-CA), Senator Charles Schumer (D-NY) and Senator Hillary Clinton (D-NY), H.R. 1038 would allow the approval of products not independently proven to be safe and effective by allowing generic manufacturers to rely on clinical research originally submitted to the FDA to support approval of different products. Currently, patients can rely on the fact that any generic drug they take is identical to the brand name product, which has already been proven safe and effective.
The Waxman-Schumer-Clinton bill ignores the scientific fact that all biologics are different; one cannot be the same or identical to the other. By not requiring follow-on products to be tested, the Waxman bill effectively subjects patients to unproven and potentially unsafe products deemed only "comparable" to the proven product.
Specifically, H.R. 1038:
- Ignores scientific differences between biologics and drugs: Biologics are much more complex than traditional pill products since they are created from living cells as opposed to chemicals. 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. H.R. 1038 ignores this scientific reality, effectively subjecting patients to generic versions of biologics that have not been subject to clinical testing. The 1984 bill creating generic drugs allowed generic manufacturers to rely on the brand name drug manufacturer's safety and efficacy data to win FDA approval if the products are proven to be the "same." In contrast, H.R. 1038 allows generic companies to seek FDA approval of "comparable biologics" that are not supported by the brand name drug manufacturer's clinical studies since the products are unique and different.
- Fails to require clinical testing of new products: Generic manufacturers would not be required to demonstrate "comparability" on the basis of human clinical trials. Instead, the bill would permit the FDA to grant approval on the basis of another company's clinical data collected for a distinct and different biologic derived under a separate manufacturing process.
- Limits the FDA's ability to require post-marketing safety studies: The bill prohibits the FDA from requiring a generic company to perform post-marketing safety studies as a condition of its approval. This will preclude the FDA from requiring studies after the generic's approval which is particularly necessary given the lowered approval standard of "comparability" instead of "sameness." In contrast, European authorities have specifically stated that post-marketing monitoring may be necessary for as much as a year after approval of a generic biologic.
- Lowers 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 can not be made. Despite this, H.R. 1038 would require the FDA to determine a generic biologic interchangeable if it can be expected to produce the same clinical result without the same safety testing.
- Fails to provide sufficient incentives to invest in costly and risky research and development: This bill provides no period of data exclusivity for innovator products, as opposed to the five years provided under the 1984 generic bill, and limits an innovators ability to enforce patents on their inventions.