Healthy Skepticism Library item: 15335

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Publication type: news

Harris G.
Bill Would Let Copycats Compete With Biotech Drugs
The New York Times 2009 Mar 26
http://www.nytimes.com/2009/03/27/health/policy/27drug.html?ref=3Dus

Full text:

Expensive biotechnology drugs would face competition from cheaper copycats, setting off a bruising battle between big drug makers and consumer advocates, under a bipartisan proposal introduced Thursday in the Senate.

The legislation would give the Food and Drug Administration broad discretion to approve copycat versions of complex medicines that are usually made from living cells. Its passage could lead to significant savings for government health programs and private insurers but could hurt large drug makers and result in fewer research incentives.

A version of the legislation that was much friendlier to large drug makers passed the Senate health committee last year but died without being voted on. Emboldened by President Obama’s election and larger Democratic majorities in Congress, consumer advocates pressed for a less industry-friendly bill. They got it.

The measure introduced Thursday cuts by more than half – to 5 years, from 12 – the time allowed before cheaper versions of biotechnology drugs could compete with the originals.

“The times are different,” Senator Charles E. Schumer, Democrat of New York, one of six sponsors of the legislation, said in an interview. “You have a new president, a new chairman in the House and most of all the need to cut costs to achieve national health care.”

A similar bill was introduced two weeks ago in the House by Representative Henry A. Waxman, Democrat of California and chairman of the Energy and Commerce Committee.

The legislation represents a serious threat to the profits of Amgen and other large biotech manufacturers who depend on the sales of older medicines that could become vulnerable to attacks from knock-offs.

“It’s a shortcut that would jeopardize patient safety and undermine our ability to develop future cures and therapies,” said Jeff Joseph, a spokesman for the Biotechnology Industry Organization, a trade group.

Consumer advocates counter that the price of some biotechnology drugs has become so high – some drugs cost as much as $100,000 a year – that some form of generic competition is essential. And they say that copycat versions of biological medicines have already been introduced in Europe without problems.

“The crushing cost of biologic drugs is leaving far too many Americans without access to life-saving treatments for devastating illnesses like multiple sclerosis and cancer,” said Nancy LeaMond, vice president of AARP.

Biotech executives have vowed to fight the legislation, saying it could result in unsafe medicines, fewer cures and fewer jobs in biotechnology centers like Boston.

“For a tiny little bit of savings, we are giving up the potential to come up with treatments for Parkinson’s and Alzheimer’s, and it’s just not very sensible,” Henri Termeer, chief executive of the Genzyme Corporation, a biotechnology maker, said in an interview.

Mr. Obama made passage of such legislation a priority last month when he estimated that copycat biotechnology drugs could yield $9.2 billion in savings over 10 years, money he planned to use to finance health care reform.

But Mr. Obama’s plan assumed that biotechnology drugs would be free of competition for just seven years, leading Senator Orrin G. Hatch, Republican of Utah and a defender of big drug makers, to say that “you will never get a bill through if that’s where the administration sticks.”

In 1984, Congress passed legislation allowing the drug agency to accept simple laboratory tests as proof that generic versions were equivalent to branded medicines. That led to the birth of the modern generics industry, which makes two-thirds of all medicines used in the United States.

But the law gave the drug agency no direction in how to handle copycat versions of complex biological medicines. The bill introduced Thursday would give the agency the discretion to approve copycats with less extensive testing.