US Senators Edward Kennedy, Mike Enzi, Hillary Rodham Clinton and Orrin Hatch have announced proposed legislation to create an approval pathway at the Food and Drug Administration (FDA) for “safe biosimilar and interchangeable biological products.”

The Biologics Price Competition and Innovation Act of 2007 (Senate bill S 623) “preserves the incentives that have fuelled the development of these life-saving medicines” by providing 12 years of data exclusivity for the brand company during which a biosimilar product may not be approved, add the legislators, who are all members of the Senate Health, Education, Labor and Pensions (HELP) Committee. The bill would also give one year of exclusivity for the first interchangeable biological product, and provides a multistep mechanism to resolve patents “in an expedited manner.”

A summary of the bill says that it would enable the FDA to approve a biosimilar product as interchangeable, “meaning it can be substituted for the brand product without the intervention of the health care provider who prescribed it. Showing interchangeability requires evidence that the biosimilar product will produce the same clinical result as the brand product in any given patient and that it presents no additional risk in terms of safety or diminished efficacy if a patient alternates or is switched between products.”

Discussing the bill, Sen Kennedy (Democrat), chairman of the HELP committee which plans to mark it up tomorrow (June 27), said that Congress has a responsibility to encourage the innovation that leads to “new medical miracles” and to see that they are affordable for the patients who need them. The bill provides “strong and responsible incentives to encourage dynamic new biotechnology companies to invest in the innovations that will produce the cures of tomorrow” and also includes strong safeguards to ensure patient safety, he added.

“I predict that very shortly, Sens Kennedy, Hatch, Clinton and I will look back at this legislation with great pride,” commented Sen Enzi (Republican), the Committee’s ranking member, who forecast that it will be seen “as a vital part of insuring our aging population has access to innovative, reliable, and safe medicines.” Describing the bill as “a good balance,” Senator Hatch (Republican) stressed that it is crucial for Congress to get this right because biologics are the future of medicine. “Just as we did with Hatch-Waxman in 1984, we’re giving incentives for both pioneer and generic drug firms,” he said.

Sen Clinton (Democrat) described S 623 as ”truly a win-win for consumers and our country,” and added: “by breaking the pharmaceutical industry’s monopoly on these medications, we will improve health care and reduce costs dramatically for seniors, families and employers.

US House panel OKs PDUFA reauthorisation

The news came after the US House Energy and Commerce Committee has voted unanimously to approve legislation drawn up by its health subcommittee to reauthorise the Prescription Drug User Fee Act, which expires September 30, through to 2012.

The bill, PDUFA 2007, includes an additional $225 million in user fees to be collected from drugmakers over the five years, mainly to finance post-market drug safety programs. It also establishes a new user fee program for direct-to-consumer (DTC) advertising, and increases transparency in the PDUFA negotiation process by including consumer and patient advocates. However, it also reduces the amount which the FDA would be able to fine companies for violations of its regulations; the health subcommittee had proposed fines of up to $20 million for a single violation and a maximum of $100 million for multiple violations, but the full panel has reduced these levels to up to $250,000 and $1 million, respectively. However, if the company continued to transgress after receiving a warning from the FDA, it could be fined up to $10 million for a single violation and a maximum of $50 million for several transgressions.

Congress must end FDA’s risk-aversion, says study

However, a new report from free-market think-tank the Competitive Enterprise Institute, called Dying For Reform has warned that every one of the proposals for FDA regulation which is currently under consideration by Congress would in fact harm rather than improve patient safety, by making it more difficult to get promising new drugs approved by the FDA and into the hands of doctors and patients.

Moreover, “these ill-conceived policies would also increase the already astronomical costs of bringing these medicines to market, raise prices, and reduce incentives for developers to undertake experimental projects,” according to the study’s authors, Henry Miller and Gregory Conko.

Contrary to perceptions, the FDA has actually become more cautious and slower to approve new medicines during the last decade, and “patients are already waiting too long for life-saving drugs to make it through regulatory red tape,” the authors write. They call for an end to regulatory “excesses” and for the introduction of competition into regulatory oversight which, they say, would allow more patients to benefit from the greater number of medicines which would be made available to them and in a more timely manner.

However, no genuine reform is possible until Congress acknowledges that no medicine is risk-free and that even those drugs which pose a considerable risk may, on balance, provide net therapeutic benefits, say the authors. Congress must then begin to force an evolution in the FDA’s culture of risk aversion, which unnecessarily delays product approvals, while the agency’s senior and mid-level managers need to be made more accountable, especially for “scientifically dubious policies and needless delays” in getting new drugs, vaccines and medical devices to the patents who need them. “The American public is literally dying for reform,” the authors claim. By Lynne Taylor