Grace-Marie Turner

The United States is the world’s leader in pharmaceutical innovation, especially in the newest form of drugs created through biomedical research. Made from living cells, biotech drugs can treat certain medical conditions for which no other medicines are available. These drugs are the cutting edge of 21st-century medicine, and the U.S. performs 80 percent of biotech research worldwide.

That could all change, though, because of a recent ruling from the Food and Drug Administration.

In December, the FDA announced it will revoke approval of the biotech drug Avastin to treat late-stage breast cancer. This decision could cause public insurance programs like Medicare, along with private insurers, to stop paying for Avastin treatment.

The ruling has been appealed by Avastin's manufacturer, Genentech, and the FDA will issue a final ruling this month. Unless the FDA reverses course, drug development and patient care in this country will be compromised.

Avastin slows the growth of cancer by cutting off the blood supply to tumors. The FDA approved the drug six years ago for the treatment of colon cancer, and the agency has since approved it to treat other cancers, including for lung, brain, and breast.

About 17,500 late-stage breast cancer patients are prescribed Avastin annually. The drug has improved the quality and length of life for thousands of women. One clinical trial found that patients given Avastin lived nearly twice as long as those not given the drug.

Last summer, the Oncologic Drugs Advisory Committee at the FDA recommended that approval for Avastin be rescinded, despite its proven benefits. Many observers speculated that the likely reason for the reversal was cost. Biologics -- the complex class of drugs Avastin falls under -- are expensive to develop and manufacture. Those expenses are reflected in the final product’s price: an individual Avastin regimen costs about $88,000 annually.

FDA agency officials have noted that doctors could still prescribe the drug “off-label.” But public and private insurers rarely covers off-label treatments. Patients would likely have to pay the whole cost of Avastin themselves. Very few can afford to do that. And so, for the vast majority of breast cancer patients, this drug effectively won’t be an option -- even though it might benefit them.

Denying Avastin will also stunt U.S. drug innovation.

It costs about $1.3 billion, on average, to develop and tests a new biologic drug and bring it to market. Genentech spent $2.25 billion to develop Avastin.

Companies are less likely to make such a huge investment if the FDA can revoke coverage after a drug is approved and take away the opportunity to recoup its investment.

Unfortunately, the FDA's Avastin decision could be just the tip of the iceberg. The Obama administration is pursuing a government-centered model of medical care on multiple fronts. The new health law creates at least 159 new government boards and agencies that will sink roots into every aspect of the health sector. Some of these non-elected boards will have the power to cut costs and restrict choices for doctors and patients.

The new Independent Payment Advisory Board (IPAB), for example, has the authority to cut Medicare reimbursement rates for doctors. Such cuts will drive physicians out of the Medicare program, and with fewer doctors available, there will be longer waits for care.

And the economic stimulus bill created a federal office to study the “comparative effectiveness” of new drugs and medical treatments. In other countries, such research has been used by government officials to deny patients access to advanced medicines.

The comparative effectiveness body in the Britain, for instance, has routinely denied public coverage for new medicines that are widely available throughout the rest of the Western world. The result has been lower quality of medical care for the British people.

Indeed, a study published in the Lancet medical journal found that only 69 percent of British women survive at least five years after being diagnosed with breast cancer, but 84 percent of American women survive at least that long.

Medical decisions need to be left up to patients and their doctors – not distant bureaucrats. The FDA needs to reverse its Avastin decision. Otherwise, patients are going to lose a vital treatment option and we'll all lose out on investment in tomorrow’s new, life-saving drugs.


Grace-Marie Turner

Grace-Marie Turner is president of the Galen Institute, a non-profit research organization in Alexandria, VA, that focuses on health reform.