Epstein: Cancer Patients Deserve Faster Access to Life-Saving Drugs
As President Barack Obama's new Food and Drug Administration team of Margaret Hamburg and Joshua Sharfstein take the reins, they must decide what to do with off-label uses of FDA-approved drugs. Right now these drugs provide immense life-saving opportunities for many sick patients, particularly those threatened by cancer. The FDA and Congress should protect physicians' and patients' right to off-label uses -- and for the first time allow drug makers to promote off-label uses that prove beneficial.
At present, no drug can reach the market without FDA approval. That approval is explicitly limited to the specific indications that have been subjected to exhaustive clinical tests, which usually take around seven years to complete, typically at the cost of hundreds of millions of dollars. Yet once a drug reaches the market, the FDA has no statutory power to "limit or interfere with the authority of a health-care practitioner to prescribe" how physicians use that drug to treat their patients.