Press Release: Senate HELP Committee Passes Bill To Allow FDA Approval Of Generic Versions Of Biotechnology Medications

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Senate HELP Committee Passes Bill To Allow FDA Approval Of Generic Versions Of Biotechnology Medications

The Senate Health, Education, Labor and Pensions Committee on Wednesday unanimously approved legislation (S 1695) that would create a regulatory pathway for the approval of generic versions of biotechnology drugs, the Newark Star-Ledger reports.

Under the legislation, generic drug manufacturers would be required to prove that no clinically meaningful differences exist in safety, purity and potency between a generic version and a brand-name version of a biotech drug. To demonstrate this, generic drug manufacturers would be required to include in their applications analytical data, animal testing and one or more clinical studies, unless FDA chooses to waive the requirements.

FDA also would have the authority to determine if a generic biotech drug is interchangeable, meaning the generic version could be substituted with the brand-name version without a physician's consent. To demonstrate interchangeability, the generic drug maker would have to provide evidence that the generic biotech drug will produce the same clinical result as the brand-name version in any given patient and that it presents no additional safety risk.

In addition, the bill would codify a multistep process to identify and resolve patent disputes (Cohen, Newark Star-Ledger, 6/28). Generic drug manufacturers would pay a user fee of about $900,000 to have generic biotech drugs reviewed by FDA (Armstrong, CQ Today, 6/27).
Market Exclusivity
The bill would provide 12 years of market exclusivity to brand-name biotech drugs, with generic biotechnology drug manufacturers required to wait a minimum of four years before challenging a biotech patent or applying to FDA for consideration of a generic version (Newark Star-Ledger, 6/28). The first generic version of each biotech drug approved would be granted one year of market exclusivity under the legislation (CQ Today, 6/27).

Both generic and brand-name drug manufacturers are "objecting" to the 12-year market exclusivity provision, according to CQ HealthBeat. Kathleen Jaeger, president and CEO of the Generic Pharmaceutical Association, in a statement said, "Such an arbitrary and excessive period of time is not only unprecedented and unwarranted, but more importantly, would unjustifiably delay access to affordable competition and choice for consumers and businesses alike." Jaeger also expressed concern over language in the bill that would allow brand-name drug manufacturers to make minor changes in their drugs and possibly secure an additional 12 years of market exclusivity.

David Sloane, senior managing director of government relations and advocacy at AARP, also expressed concern over this provision. Sloane said, "Our members cannot afford to wait a minimum of 12 years for medication therapies that aid in the treatment of diseases like multiple sclerosis and cancer."

Committee Chair Edward Kennedy (D-Mass.) said the legislation takes steps to prevent brand-name drug manufacturers from extending their market exclusivity through small changes.

The Biotechnology Industry Organization criticized the bill for not granting brand-name drug manufacturers 14 years of market exclusivity. BIO President Jim Greenwood said, "We continue to believe ... that 14 years of exclusivity is the needed period required to strike the right balance between providing incentives for innovation and follow-on product entry," adding, "We look forward to working with members of Congress as the bill moves forward to address this need" (Carey, CQ HealthBeat, 6/27).

Procedural Maneuvers
Kennedy said he would like to include the measure in conference negotiations with the House on legislation that would overhaul FDA.

However, House Democratic leaders and some committee members would have to agree to the proposal, and Kennedy "did not give any assurances Wednesday that they would do so," according to CQ Today (CQ Today, 6/27). House Energy and Commerce Health Subcommittee Chair Frank Pallone (D-N.J.) supports adding the generic biotech drug legislation to the FDA bill and noted that the Senate left a placeholder in its version of the FDA legislation to insert the language once it had been agreed upon.

However, the "Senate's move has caused confusion in the House, which can reserve a point of order claiming the move violates a rule," according to CongressDaily (Edney, CongressDaily, 6/28). If House Democratic leaders do not agree with the Senate's version of the legislation and decide to hold a round of hearings and mark ups, the proposal "could likely be left out" of conference negotiations, CQ Today reports (CQ Today, 6/27).

House Energy and Commerce Committee Chair John Dingell (D-Mich.) said that he is not sure if the House will be ready to discuss generic biotech drugs by the time conference negotiations begin, which is expected to occur in July (CongressDaily, 6/28).

Comments
Sen. Orrin Hatch (R-Utah) described the bill as a "classic compromise," in which neither side is completely happy. Hatch said, "If the generics endorse it, it brings a lot of angst to the pioneer companies. If the pioneers endorse it, then the generics think, 'Well, is this good?' I think they're just using good discretion" (CQ Today, 6/27).

Senate HELP Committee ranking member Mike Enzi (R-Wyo.) said the legislation "captures a delicate balance between access and innovation while maintaining the highest standards of safety."

Kennedy said the bill will "save American families and the American government billions of dollars by allowing follow-on and interchangeable (biologic) products to the market at reduced prices."

Sen. Hillary Rodham Clinton (D-N.Y.) said, "There are drugs right now that, once we pass this bill, will be on the way to generic versions that will be much more affordable to many people" (Newark Star-Ledger, 6/28).

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