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Last summer, the Oncologic Drugs Advisory Committee at the FDA recommended that approval for Avastin be rescinded, despite its proven benefits.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.