Healthy Skepticism Library item: 15969

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Publication type: news

Mundy A.
Blood Boils Over Bill To Protect Biotech Drugs
The Wall Street Journal 2009 Jul 13
http://online.wsj.com/article_email/SB124744245402430031-lMyQjAxMDI5NDE3MzQxNDMyWj.html

Full text:

The biotech industry is moving closer to a victory in Congress that would protect lucrative drugs from generic-drug competition for a lengthy period, though the issue continues to rile up lawmakers and consumer advocates.

The Senate Health, Education, Labor and Pensions Committee will be looking at a bill this week that would grant so-called biologic drugs — those engineered from living cells — made by companies like Amgen Inc. a total of 13½ years of intellectual-property protection, which is about twice the length of time proposed by the White House.

The proposal, introduced by the committee’s chairman, Sen. Edward Kennedy (D.,Mass.), would be part of an ambitious health-care overhaul sought by President Barack Obama. It may prevail because it would help keep the pharmaceutical industry on board with the overhaul, said industry lobbyists and Senate staffers.

But the question of how long to protect brand-name biologics’ intellectual property — referred to as their ‘exclusivity’ — has caused a rift in the health committee, which oversees the Food and Drug Administration, and in the overall Senate, industry representatives and Senate staff said.

It has also sparked an advertising battle between consumer groups, which want a shorter period of exclusivity for biologics, and the industry, which has said such an approach would hamper innovation.

Biologics, such as Amgen’s Epogen for cancer patients, are generally made from proteins manufactured in living cells, and they are far more complex than traditional chemical drugs. The biologics industry is growing at 18% a year and could hit $100 billion in sales by 2011, according to generic drug makers.

Without sufficient exclusivity, “the biotech industry will not have the incentive to take high risks required for development and innovation in biologic life-saving drugs,” said industry lobbyist Jim Greenwood.

Sen. Kennedy, whose state includes large biotechnology companies and research centers, has consistently advocated the brand-name makers’ position, as have some other Democratic health committee members, including Patty Murray (D., Wash.) and Barbara Mikulski (D., Md.).

But some other Democratic senators, including Chuck Schumer of New York and Sherrod Brown of Ohio, as well as the chairman of the House Energy and Commerce Committee, California’s Henry Waxman, favor strict limits on brand-name biotechnology products to cut drug costs.

Messrs. Brown and Schumer and Mr. Waxman have introduced separate bills this year, supported by consumer groups, that propose a base of five years’ exclusivity, with a possibility of extension.

“Biotechnology start-up involves high risk and high cost, but you can’t give these companies open-ended protection from generics,” said Sen. Brown in an interview.

A report in June by the Federal Trade Commission rejected the industry’s stance and said 12 to 14 years of exclusivity would harm patients by unnecessarily delaying access to affordable drugs. The White House recently wrote lawmakers that it favors seven years.

The Kennedy legislation is expected to go to the Senate Finance Committee, which is driving the health-care overhaul package. Its chairman, Max Baucus, has supported longer exclusivity for brand-name makers. His staff said he wouldn’t comment before his bill is released.

Leaders of the health committee are trying to avoid a public showdown over the issue and may not produce a formal proposal until there is more unanimity on their panel, industry representatives and Senate staffers said.

Mr. Schumer, who serves on the finance committee, said he thinks there may be stronger support for lower exclusivity in the Senate as a whole.

A separate House bill strongly propelled by the Biotechnology Industry Organization, the biotech lobby, and PHRMA, the Pharmaceutical Research and Manufacturers of America, which represents brand-name drug makers, would provide at least 12 years of protection for brand-name biologics.

AARP, the lobby group for seniors, recently wrote health-committee members saying it could not support a broader health-care bill that included “double-digit exclusivity.”

The group is in an escalating advertising war against BIO and PHRMA. It has been running full-page ads in political publications saying: “Don’t believe brand-name companies’ myths” about needing exclusivity.

BIO, the industry’s lobby in Washington, struck back in radio advertisements last week accusing seniors of wanting a “free ride” for generic makers.

The biggest wave of commercials so far has come from PHRMA, whose members include some biotech companies. Radio ads accused supporters of short exclusivity periods of selling out American workers.

The ads claim shorter exclusivity causes job loss, and say that pending proposals to allow faster generic versions would “outsource jobs to copycat manufacturers in India and China.”

Corrections & Amplifications
The lobby for the drug industry was incorrectly identified as the Pharmaceutical Research and Manufacturers Association in a previous version of this story. It should be Pharmaceutical Research and Manufacturers of America.