Online Extra... Senate Panel Moves Ahead on Generic Biologics Bill

WASHINGTON—The Senate Health, Education, Labor and Pensions (HELP) Committee took the first major step toward allowing sales of cheaper generic versions of biologic drugs, approving a compromise bill that did not completely satisfy any of the parties who have a stake in the measure.

The contentious nature of the legislation was evident in the qualified support given by interested groups. While all praised the effort by the senators to craft a compromise, they also suggested there are deficiencies in the bill that may need to be rectified as the legislation makes its way through Congress.

The HELP bill would allow the Food and Drug Administration to approve generic versions of brand-name biologics, which are expensive drugs made from living organisms and used to treat diseases like cancer and multiple sclerosis. Sales of biologics, considered by many as wonder drugs, mounted to $40.3 billion in 2006.

The bill would give biotech companies 12 years of exclusivity for a brand-name drug before generic versions could be sold. The companies had pressed for a 14-year exclusive deal, while generics manufacturers called for five years.

In a nod to generics companies, the HELP measure opens the way for speedier approval for their versions of brand-name biologics, in some cases allowing the process to go forward without clinical trials. The legislation would also allow the FDA to designate generic biologics as interchangeable, meaning they are so close to their brand counterparts that a pharmacist can substitute the generic for the brand-name drug without a physician’s approval—much the way current law applies to traditional prescription drugs.

Currently, generic versions of many traditional drugs are routinely provided by pharmacies around the nation, and brand-name versions can be given only when doctors specifically prescribe them. This practice lowers costs for millions of consumers.

In a letter to HELP Committee Chairman Edward Kennedy, D-Mass., David Sloane, AARP’s senior government relations manager, thanked the senator for his leadership on the issue. "Your legislation seeks to create a pathway for the approval of generic biologics," he wrote. But Sloane added that the 12-year exclusivity period is too long and would "unnecessarily delay the introduction of generic biologics."

AARP is also concerned that the legislative language might be too vague, allowing a biotech manufacturer of brand-name drugs to extend the 12-year period by simply changing the dosage or making some other small change to retain a brand-name’s right to exclusivity.

Representatives of the pharmaceutical industry hesitated to give the bill unqualified approval, saying that the "abbreviated approval pathway" for the generic versions of biologics might not protect patient safety. The Pharmaceutical Research and Manufacturers of America said in a statement it was also concerned about preserving "incentives for innovation," such as having sole rights to sell a drug for many years before generics are permitted.

Biologic drugs such as red blood cell boosters and arthritis medicine can cost tens or even hundreds of thousands of dollars annually, pricing many ill people out of the market for drugs that could radically improve their lives. In testimony before a House committee earlier this year, an AARP representative told the story of Bonnie Cramer, an AARP board member who suffers from rheumatoid arthritis and takes the biologic drug Enbrel, which has greatly diminished her symptoms. In the testimony, Cramer was quoted as saying that she knows of other arthritis sufferers who can’t afford the drug and have seen their mobility decrease dramatically.

In calling for cheaper, generic versions of the drug, Cramer said, "Having lived with this disease for 40 years, I know how incapacitating it can be and how the pain can be unbearable. To know that [the drug] cannot be obtained by other people is brutal. How do you tell someone that they cannot have a treatment that may alter their lives significantly?"

Agreement on the bill was bipartisan. "Just as generic drugs have helped bring down the costs of medicines for millions of Americans, new 'follow-on' versions of breakthrough biologics will make these innovative treatments more affordable for the patients who need them," Kennedy said.

Joining Kennedy in pushing the legislation were Senators Orrin Hatch, R-Utah; Mike Enzi, R-Wyo.; and Hillary Clinton and Chuck Schumer, both Democrats from New York. Hatch said the bill represents a "good balance," while Enzi stressed that it captures a "delicate balance between access and innovation while maintaining the highest standard of safety."

Clinton said the bill will help stretch federal budget dollars spent on Medicare and Medicaid while helping more Americans get affordable treatments.

Kennedy plans to attach the biologics bill to a Senate-passed FDA bill. Similar legislation, including the AARP-backed bill sponsored by Rep. Henry Waxman, D-Calif., is making its way through the House this year.