Analysis of Waxman H.R.1427

The “Promoting Innovation and Access to Life-Saving Medicine Act”, H.R. 1427, permits approval of unsafe prescription drugs and threatens patient safety. The bill would for the first time permit the FDA to approve follow-on versions of complex biological products that have not been fully tested in clinical studies to verify their safety and effectiveness.

Sponsored by Rep. Henry Waxman (D-CA), H.R. 1427 would approve products not proven to be safe and effective by allowing manufacturers of follow-on biologics 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 version of a traditional drug they take is the “same” as the brand name product, which has already been proven safe and effective. This bill ignores that standard for ground-breaking biologic drugs, and effectively subjects patients to unproven and potentially unsafe follow-on products deemed only “comparable” to the proven product.

Specifically, H.R. 1427 would:

Lower the standard of FDA approval from “sameness” to “comparability.”
The 1984 bill creating generic drugs allowed manufacturers to rely on the brand name drug maker’s safety and efficacy data to win FDA approval if the products are proven to be the “same.” In contrast, H.R. 1427 allows companies manufacturing follow-on versions of biologics to seek FDA approval of “comparable” products” that are not supported by the brand name drug manufacturer’s clinical studies since the products are unique and different.

Ignore 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 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 follow-on replication of a similar product. H.R. 1427 ignores this scientific reality, effectively subjecting patients to versions of biologics that have not been subject to clinical testing.

Fail to require clinical testing of new products.
Manufacturers of follow-on biologic products 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.

Fail to provide guidelines for post-marketing safety studies.
The bill contains no provision to direct the standards the FDA should require for post-marketing safety studies and monitoring.

Lower the standard for “interchangeability.”
Under current law, the FDA advises patients that both brand name and generic copies of traditional drugs 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. 1427 would require the FDA to determine a follow-on biologic interchangeable if it can be expected to produce the same clinical result without the same safety testing.

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