Washington Editor

WASHINGTON - While Sen. Edward Kennedy (D-Mass.) earlier this week proposed that innovator biologic makers be granted nine years of data exclusivity with the potential of four and a half additional years - nearly the 14 years sought by the Biotechnology Industry Organization (BIO) - the measure leaves open the possibility that many biologics would receive no exclusivity, the biotech trade group charged.

BIO maintained that the language as proposed in Kennedy's measure provides nine years of base data exclusivity only to a new major substance. Therefore, any biologic that is even similar to a previously approved product, in some undefined way, could get zero years of exclusivity if Kennedy's proposal is adopted, the biotech lobbying group asserted.

In addition, BIO alleged, the nine years pertains only to those new biologics approved after the bill's passage, with products approved even one day before the legislation becomes law getting zero years of exclusivity, providing no protection.

"Such an abbreviated and uncertain period of exclusivity could lead to a dead end for many new biomedical advancements and potential cures for devastating diseases, such as cancer, Parkinson's, Alzheimer's, multiple sclerosis and a host of rare diseases," BIO contended. "It also would jeopardize more than 7.5 million U.S. jobs driven by biotechnology and our nation's leadership in biomedical innovation."

But the Generic Pharmaceutical Association said BIO was crying wolf.

"It is a shame that in an attempt to protect the profits of Amgen, Genentech and other biotech companies, BIO and its supporters are misleading Congress," said GPhA CEO Kathleen Jaeger. "It's time to put patients over profits."

At press time Thursday, Kennedy's provision had yet to be voted on in a markup session convened by the Senate Health, Education, Labor and Pensions (HELP) Committee, where more than 300 amendments are being considered for the committee's health reform legislative package, known as the Affordable Health Choices Act. Creating a regulatory pathway for the FDA to approve follow-on biologics (FOBs) is just one legislative issue the HELP committee has been grappling with this week.

BIO supports a bill introduced in the House by Reps. Anna Eshoo (D-Calif.), Joe Barton (R-Texas) and Jay Inslee (D-Wash.), H.R. 1548, which calls for 14 years of data exclusivity. Another House bill, H.R. 1427 introduced by Rep. Henry Waxman (D-Calif.), supports five years of data exclusivity, with a six-month extension for pediatric products and a six-month extension for new indications. (See BioWorld Today, March 13, 2009, and March 19, 2009.)

The White House has said that seven years would be a "generous compromise," while the Federal Trade Commission has said that no period of data exclusivity is needed. (See BioWorld Today, June 12, 2009, and June 29, 2009.)

GPhA said that while it still supported Waxman's bill, it praised the White House's seven-year compromise proposal as a way to "move this issue forward."

The group did not comment directly about whether it supported Kennedy's nine-year proposal.

But BIO maintained that the new Kennedy measure "would undermine hope for potential cures and new advanced medicines."

"The proposal would provide a limited and highly uncertain period of data exclusivity that would chill the investment required to improve existing drugs and develop the next generation of medicines and potential cures for patients," BIO argued.

"In the end, this new proposal would provide fewer incentives for the uniquely American biotech industry than the European Union, provides and it would create an incredibly complicated structure filled with uncertainty that would scare off investors and, in turn, potentially stifle efforts to pursue medical advancements and breakthroughs for patients," the biotech group stated.

BIO also contended that Kennedy's proposal for nine years of data exclusivity was a "stark break" from a bill the Massachusetts senator co-sponsored with Sen. Mike Enzi (R-Wyo.) during the 110th Congress, which called for 12 years of data exclusivity.

"We worked hard to get to that 12 years," Sen. Orrin Hatch (R-Utah) said earlier this week during the markup session. "Frankly, I can't understand why we don't realize that if we take away the robust period of data exclusivity from brand companies, there aren't going to be any products for the generics to copy. It is just that simple," Hatch declared.

He noted that biotechs are dependent on venture capital to fund their development.

"It is going to cost $1 billion or more and take 15 years in many cases to get to a hopefully successful drug, and if they don't have enough data exclusivity protection, they are just not going to do it," he said.

However, Hatch said he strongly supported a pathway for FOBs approval.

"This is one area where we might save more money in health care than any other, other than, in my opinion, all forms of stem cells research," he said.