Washington Editor

As Congress returns from its August recess this week, groups representing the biotechnology and drug industries are making last-ditch efforts to influence the outcomes of bills that affect product safety, patent laws and generic competition.

The culmination of several bills this year, said James C. Greenwood, chief executive officer of the Biotechnology Industry Organization (BIO), has created a "perfect storm" on Capitol Hill for the biotech industry.

And, he told BioWorld Today, what lawmakers ultimately decide could have long-term effects on whether biopharmaceuticals remain an attractive investment sector.

"If we're good at what we do, it's possible for us to get through this [legislative] session in a way that will make sure there are no new serious threats and maybe some new opportunities," said Greenwood, a former member of Congress.

Although the 110^th Congress had pledged to move swiftly to reauthorize the Prescription Drug User Fee Act (PDUFA), which expires Sept. 30, lawmakers could not agree on the House and Senate bills before leaving town last month.

House members remained adamant that certain safety provisions stay in the version of the legislation they passed.

Unfortunately, Greenwood said, PDUFA's reauthorization is occurring in the post-Vioxx-withdrawal environment in which concerns have been raised about whether the FDA, which relies on industry user fees for much of its budget, is favoring quick approvals over safety.

"There's a lot of wild allegations flying around," Greenwood said.

While it supports the reauthorization of user fees, he said, BIO wants Congress to provide more funding to the FDA. Greenwood noted that user fees have gone from being 7 percent of the FDA's budget to 59 percent.

"Congress should fund the FDA better so that at least we can get more to a 50-50 split between public dollars and private dollars paying for drug approvals," he said.

Some 'Bugaboos' Gone

While neither the House nor the Senate PDUFA bills are perfect, Greenwood said, lawmakers have removed a lot of the "bugaboos" that plagued the early legislation.

The Generic Pharmaceutical Association (GPhA), said spokesperson Andrea Hofelich, is also keeping a watch on several measures in both versions of the PDUFA legislation, particularly the citizen petition provision in the Senate bill.

If passed, that measure would require the approval process for a generic product to move forward while FDA considers a citizen petition.

Currently, regulators generally will not clear a generic product for the market until all underlying issues in a citizen petition have been addressed.

GPhA contends that brand-name product makers file citizen petitions in an attempt to delay a generic competitor's entrance to the marketplace.

GPhA also would like to see passed under PDUFA a measure approved on June 27 by the Senate Health, Education, Labor and Pensions Committee that would establish a regulatory pathway for the licensure of follow-on versions of approved biologics, sometimes called biosimilars or biogenerics.

The Public Health Service Act, under which biologics are licensed, does not contain an abbreviated approval pathway analogous to the process used under the Food, Drug, and Cosmetic Act for generic drug approvals, according to the FDA.

However, the agency has approved some follow-on biologics under the FD&C Act, such as GlucaGen, Hydase, Fortical and Omnitrope, Janet Woodcock, FDA's deputy commissioner and chief medical officer, told Congress in March.

The Biologics Price Competition and Innovation Act, S. 1695, would create a safe pathway for the approval of follow-on biologics, Hofelich said.

She argued that follow-on biologics are needed in the U.S. to give millions of patients with serious diseases, such as heart disease, cancer, and diabetes, who otherwise could not afford treatment with expensive biologics, access to affordable life-saving therapies.

Assurances Sought

Under the bill, a follow-on biologic applicant would be required to demonstrate that there are no clinically meaningful differences in safety, purity and potency between its product and the brand product. The bill also allows the FDA to approve a follow-on biologic as interchangeable. However, the applicant must provide evidence that its product will produce the same clinical result as the brand product in any given patient and that it presents no additional safety risks or diminished efficacy if a patient alternates or is switched between products.

One thorn in the bill for GPhA, Hofelich said, is a provision that gives the innovator 12 years of data exclusivity during which a follow-on biologic may not be approved.

Language in the provision also allows the innovator to make multiple minor changes to their brand products and receive up to 12 years for each change—a practice Hofelich called "evergreening."

However, GPhA contends, lawmakers who introduced the follow-on biologics bill, or FOBs, did not intend for the evergreening language to be included in the final version that passed the committee in June.

Hofelich said GPhA will be working with Senate staff over the coming days attempting to have that language removed from the legislation.

Greenwood called FOBs "completely stacked on the side of generic companies."

BIO, he said, is working to keep the FOBs measure separate from the PDUFA legislation to keep the user fee bill from getting bogged down and to prevent FOBs from being accelerated before Congress can fully consider it.

In the fight over patent reform, Greenwood said, the biotech industry is facing a goliath among adversaries: the information technology industry.

Because IT companies compete in a global environment where products must enter the market at rapid speed to avoid obsolescence, that industry is seeking a quick way around patent infringement cases, he said.

However, Greenwood said, the biotech industry has a business model that takes up to 15 years in most cases for a product to reach the market. Biotech firms also rely heavily on the strength of their intellectual property.

A patent infringement case that undermines a biotech firm's intellectual property, he said, can mean death to a company that is seeking venture capital funds, especially smaller firms.

One measure BIO is supporting under the Patent Reform Act of 2007, or H.R. 1908, he noted, is reform of the inequitable conduct law.

BIO contends that the inequitable conduct law is frequently abused as a defense in patent litigation by which infringers can allege that otherwise valid patents are unenforceable due to alleged misrepresentations or omissions during the patent application process.

A charge of violating the inequitable conduct law, Greenwood noted, can result in a firm losing its patent.

BIO, he said, is advocating for penalties for violations of the inequitable conduct law to more directly relate to the violation "and not create a death penalty with regard to your patent."

GPhA, Hofelich said, supports the current inequitable conduct law and is working with members of Congress to ensure that patent reform legislation supports the integrity of the U.S. patent system.