Washington Editor

WASHINGTON - The biotech and pharmaceutical makers' support for getting a follow-on biologics bill passed this year is an attempt to "cut a deal" with Congress to secure at least 12 years of data exclusivity, said Kathleen Jaeger, CEO of the Generic Pharmaceutical Association (GPhA).

"They want unprecedented and excessive market exclusivity and patent protections to ensure their monopolies," she said.

"We believe members of Congress will recognize that cutting such a deal will put brand profits before patient needs," Jaeger noted.

GPhA contends that biotech and pharmaceutical makers have shifted their focus from a science-based concern about the clinical effects of follow-on biologics to an effort to protect patents and profits.

But Jim Greenwood, CEO of the Biotechnology Industry Association (BIO), argued that the biotech industry's push to have a bill passed in 2008 giving the FDA a regulatory pathway to approve follow-on biologics is not a sudden turnaround.

"There was a pretty wide assumption in the media that BIO and our industry would stand in opposition to the passage of any kind of follow-on biologics, that we wouldn't want the competition," he told reporters Thursday at a media briefing. "That's not been our approach. Ours has been to encourage the Congress to adopt follow-on biologics legislation."

However, Greenwood said, BIO opposed the inclusion of follow-on biologics legislation in last year's FDA reform package, which was enacted Sept. 27.

BIO continues to oppose legislation introduced last year by Rep. Henry Waxman (D-Calif.), but supports a bill passed by the Senate Health, Education, Labor and Pensions Committee last June, which, if enacted, would give biologic drugmakers 12 years of data exclusivity, Greenwood said.

Waxman has suggested that biotech makers be allowed only five years of data exclusivity, a proposal supported by the generic drug industry.

BIO also is favoring bills by Reps. Jay Inslee (D-Wash.) and Anna Eshoo (D-Calif.). Eshoo's bill, which she is drafting in concert with Rep. Joe Barton (R-Texas), would provide 12 years of data exclusivity plus additional years for seeking new indications and conducting pediatric trials, Greenwood noted.

However, he added, BIO is reserving its endorsements of the Eshoo-Barton bill until the legislation has been introduced and the group has scrutinized all measures contained in the bill.

BIO is pressing for passage of a follow-on biologics bill this year, Greenwood maintained, so that the legislation does not wait until a new Congress and administration are educated about the topic and so that the whole legislative process does not have to begin anew in 2009.

The biotech industry group is concerned that Congress may allow interchangeability of follow-on biologics, which would permit pharmacies to switch a brand-name biologic with a follow-on biologic — a common practice done with generic pharmaceuticals, typically without a physician's supervision, because of insurance coverage issues.

Some generic biopharmaceuticals approved by the FDA under the Food, Drug and Cosmetic Act that allow for interchangeability and are classified as complex include protamine, calcitonin, corticotropin, somatropin and menotropin, according to the GPhA.

BIO also is concerned about issues of immunogenicity related to follow-on biologics, Greenwood said.

Immune responses to administered protein products can be extremely serious or life-threatening, according to regulators, and the ability to predict immunogenicity of a protein product is extremely limited.

Congress should not get in the way of what physicians have determined are the best drugs for their patients, Greenwood said, adding that BIO is concerned that insurance companies will restrict access to brand-name biologics in favor of cheaper follow-on biologics, regardless of immunogenicity concerns.

Stupak Calls for FDA Chief to Resign

Rep. Bart Stupak (D-Mich.) is calling for FDA Commissioner Andrew von Eschenbach to step down.

Stupak has insisted that new laws and more funding and resources alone will not fix the FDA, but new leadership is required now to improve the embattled agency, even though a new administration will take control in 2009 and von Eschenbach may have less than a year left to serve.

Stupak's call for von Eschenbach's resignation was not triggered by any specific incident, his spokesman Nick Choate told BioWorld Today, but rather the accumulation of problems at the agency since the commissioner took over in December 2006.

While Congress has held numerous hearings and several government reports have been issued in recent years highlighting the problems at the FDA, von Eschenbach in testimony has "painted a glowing picture of how things are improving" at the agency, Choate said.

Yet, he said, the revelation last week that the FDA never inspected a Chinese plant where the active ingredient for Baxter International Inc.'s blood-thinning product heparin is made is more evidence of the agency's failures to protect the public under von Eschenbach's reign as chief.

The FDA and Baxter notified the public last week that four people died and hundreds of others became ill after having severe allergic-type reactions to heparin.

Baxter has temporarily stopped manufacturing the product.

Ranking member of the Senate Finance Committee Sen. Charles Grassley (R-Iowa) has demanded the timeline from von Eschenbach of events that led to the agency's discovery that the Chinese plant had not been inspected, and the status of the FDA's investigation about the four patients who died after receiving heparin.

Grassley noted that the disclosure about the heparin deaths came on the heels of a congressional investigation that revealed that only 11 pharmaceutical plants in China were inspected during 2007, even though hundreds of facilities there are producing active pharmaceutical ingredients used in medications sold in the U.S.