Each year, thousands of severely ill cancer patients seek access to cancer treatments that are not yet approved or on the market but are found to have some promising results in preliminary studies.
Now the United States government wants to make things easier and consider the requests of patients. On Monday, at the American Society of Clinical Oncology conference in Chicago, the Food and Drug Administration (FDA) announced a project to have the regulatory body become the intermediary.
Rather than making physician plead their case first to drug companies and then to the agency – if the drug company agrees to provide the medication, the FDA will take the initial step and assign a staffer to do the paperwork as quickly as possible. This way, a company knows that the FDA had already considered it appropriate when it gets a request.
The FDA official Dr. Richard Pazdur said, “We are here to help. We are not here to make a drug company give a specific drug to a patient. We don’t have that authority.”
However, the agency gets very little information on how many requests are declined and why. Dr. Pazdur noted that the current system is cumbersome and sometimes unfair.
He said, “We do not want to have the situation where somebody who screams loudest gets the drug and other worthy candidates don’t.”
Please note the government project only involves cancer drugs and no other drugs.
“The new FDA project is absolutely going to change things and push more companies to say yes,” said Nancy Goodman, the founder of an advocacy group, Kids v Cancer The agency runs a website with links to drug companies’ policies and contact information for patients. It will quickly approve the vast majority of these requests whenever a drug company has granted access.