Generic Drug Firm Makes a Case for Its Brand

Posted November 17, 2009 at 6:15pm

Teva Pharmaceuticals, a leading manufacturer of generic drugs, has been aggressively lobbying Congress to scrap provisions in the health care bills it claims would shut it out of the biologic drug market for too long.

But the company is under fire from critics, including those who represent the biotechnology industry, who accuse Teva of being hypocritical for also fighting efforts to produce generic versions of its own brand-name drug, Copaxone.

The complaints underscore how bitter the high-stakes battle between generic and brand-name drug companies has become as Congress decides how boldly to restrict entry into the potentially lucrative generic biologic, or biosimilar, market.

Mary Pendergast, a former Food and Drug Administration official and consultant whose clients include a leading biotechnology firm, Genentech, said Teva was not being consistent with regard to the approval process for generic drugs.

“Depending on which business hat they are wearing, they are coming up with different scientific standards,— Pendergast said.

But Debra Barrett, the chief Teva lobbyist in Washington, D.C., dismissed such charges, saying the company has always maintained that the FDA should have discretion to decide whether and when generic drugs should be approved. The company just doesn’t want Congress to enshrine certain mandates into law, she said.

“It is not only not hypocritical, it is consistent,— said Barrett, who is senior vice president of government affairs for Teva, an Israeli-based company.

Legal Challenge

At issue is Teva’s position that generic companies should not be able to manufacture their version of Copaxone, which is used to treat multiple sclerosis, without conducting full clinical trials, which can take years. The company has used the courts and FDA to try to stop such efforts.

In March, the FDA declined to review a citizen petition filed by Teva with the agency requesting that generic companies not be allowed to proceed with their versions of Copaxone without conducting human trials. The FDA responded that it was premature to issue a ruling.

In September, the FDA accepted an application for review from Mylan, a Pennsylvania-based drug company, which is seeking approval for a generic version of Copaxone. That move prompted a legal challenge by Teva, which claimed an infringement of its intellectual property rights.

“Copaxone is a highly complicated product to develop and manufacture and given the inability to fully characterize the active ingredients of Copaxone, Teva has serious doubts about any generic applicant’s ability to demonstrate conclusively that the composition of its product is identical to that of Copaxone,— the company stated in an Oct. 16 news release in which it announced its lawsuit against Mylan.

The release added that any applicant “should conduct full-scale placebo-controlled clinical trials.—

Mylan did not respond to a request for comment. Teva has also filed a similar lawsuit against Momenta Pharmaceuticals Inc. and Sandoz Inc.

Meanwhile, during committee debate in the House over a biologic piece of health care legislation, Teva opposed a proposal by Rep. Anna Eshoo (D-Calif.) that would have mandated that generic drug companies conduct clinical trials on products they are developing.

An Inconsistent Message?

Pendergast said such actions showed that Teva has not been consistent.

“Teva’s citizen petition is 180 degrees different than what it has been saying to Congress about biosimilar legislation,— Pendergast said.

Pendergast said her criticism of Teva is not based on her affiliation with biotechnology companies, noting that her consulting firm also advises generic companies. But she also has strong current and past ties to the biotechnology industry. She served as executive vice president for government affairs for Elan Corp., which bills itself as a neuroscience-based biotechnology company. She is on the board of directors of ARCA biopharma, which is focused on developing genetically targeted therapies for heart failure.

Barrett said Teva has never opposed generic companies conducting clinical trials but believes the FDA should decide on a case-by-case basis whether to order them.

She also noted that Copaxone, while taken by injection, is not a biologic drug, so the legislation before Congress would not affect it. Nevertheless, she said the principle remained the same: The issue of whether to require clinical trials should remain with the FDA and not be written into law.

Even though the House legislation does not contain the mandate on clinical trials, the generic and brand-name drug industries still remain at odds over the health care legislation.

Both the House version and legislation passed by the Senate Health, Education, Labor and Pensions Committee still include a provision — opposed by the generic industry — that gives a minimum 12-year market exclusivity to brand-name biologics.

Generics Vs. PhRMA

The generic companies have lobbied to reduce the market exclusivity to between five and seven years, which they argue will help reduce overall health care costs by ensuring a greater supply of cheaper biologic drugs.

Last month, a coalition, which included the Generic Pharmaceutical Association as well as several unions, consumer groups and the AARP, wrote to Congressional Democratic leaders urging them to revise the biologic provision or scrap the whole section.

“If the biogenerics provisions are not improved then Congress will have missed a significant opportunity to meaningfully reform our health care system and should drop the biologics provision from the legislation,— said the Oct. 26 coalition letter to Senate Majority Leader Harry Reid (D-Nev.) and Speaker Nancy Pelosi (D-Calif.).

However, the lobby for the brand-name drug companies and biotechnology firms is well-funded and has many allies in Congress.

The New York Times recently reported that 42 House Members inserted statements in the Congressional Record that were drafted, in whole or part, by Genentech lobbyists that supported the biologic provision in the health care bill.

The brand-name drug companies, led by the powerful Pharmaceutical Research and Manufacturers of America, have argued that the 12-year period gives them the time needed to break even on the substantial investment they are making in cutting-edge drugs.

Kathleen Jaeger, president of the Generic Pharmaceutical Association, admitted that drug companies and the biotechnology industry were fierce competitors.

“They are going to use every tactic in their playbook,— she said.