The Biotechnology Industry Organization has urged the US Congress not to link a Food and Drug Administration approval pathway for follow-on biologics to legislation reauthorising the Prescription Drug User Fee Act (PDUFA), which expires on September 30.
Follow-on biologics, also known as biogenerics, involve difficult questions surrounding science, patient safety and intellectual property, and if Congress were to rush to develop a pathway for their approval, this would be “to the detriment of patients waiting for new therapies, FDA’s internal scientific capabilities and biomedical innovation,” warned BIO’s chief executive, Jim Greenwood.
The industry group made its plea on the day of a House Oversight and Government Reform Committee hearing to discuss a regulatory pathway for biogenerics. BIO did not testify, but it used the opportunity to launch a strong attack on Committee chairman Henry Waxman (Democrat)’s Access to Life-Saving Medicine Act (HR 1038), claiming that this bill would fail to ensure patient safety and “eviscerate” incentives for R&D.
Congress should also be wary as it looks to follow-on biologics to provide savings in federal health care programmes, says BIO, which has dismissed recent estimates of substantial savings as deeply flawed. It has also pointed out that, according to a report published in March by the Congressional Research Service, high manufacturing costs and the need for additional safety and efficacy trials to test follow-on biologics, plus “augmented efforts directed at doctors and patients to encourage the use of similar, but not identical, drugs, are expected to add to the prices associated with the follow-on product.”
In a further move, BIO has written to influential Congressional committee leaders, setting out the key principles which, it says, must guide the creation of any statutory pathway for the approval of biogenerics.
Specifically, it states that:
– patients should not have to accept greater risks or uncertainties in using a follow-on biologic than an innovator product. Congress should ensure that approval of follow-on biologics is based on the same rigorous standards of safety, purity and potency applied by the FDA for the approval of pioneer biotechnology products;
– biologics are much more complex than small-molecule chemical drugs, so Congress should recognise that the methods used to show that one chemical drug is the same as another are different from, and insufficient for, biologics. Also, small product or manufacturing differences in biologics can result in significant safety and/or effectiveness differences;
– the current state of science is insufficient to establish interchangeability for complex follow-on biologics. Therefore, Congress should ensure that patients are not given follow-on biologics unless they are expressly prescribed by a physician;
– to preserve incentives for R&D and new indications for innovative treatments, any statutory pathway for follow-on biologics must: include substantial non-patent data exclusivity; respect intellectual property and other legal rights; and provide adequate notice and process rights;
– manufacturers of innovator products must be given “full and fair opportunities to engage Congress and other stakeholders in a meaningful public process.” Also, under any statutory pathway, the FDA must follow a transparent and public process in determining data requirements for the approval of specific follow-on biologics; and
– Congress must ensure that the workload associated with follow-on biologics does not harm the FDA’s ability to review new drugs and biologics efficiently, and that new treatments continue to have the highest review priority.
The letter has been sent to Senators Edward Kennedy (Democrat) and Mike Enzi (Republican), chairman and ranking member, respectively, of the Senate Health, Education, Labor and Pensions (HELP) Committee, and to Representatives John Dingell (Democrat chairman) and Joe Barton (Republican ranking member) of the House Energy and Commerce Committee.