FDA boosts access to experimental cancer drugs

BETHESDA, Md. (WPVI) -- U.S. drug regulators are launching a project aimed at giving more cancer patients a chance to try treatments that are not yet on the market, but that have shown some promise in early testing.

Thousands of gravely ill cancer patients each year seek "compassionate use" access to treatments.

Now the government wants to make this easier and give more heft to the requests.

Under the new "Project Facilitate" program announced Monday, the Food and Drug Administration will work directly with doctors from any medical center, helping them get access to experimental drugs faster for their patients.

They will help oncologists with paperwork to make the patient's case to drug companies.

Some people who struggled to find experimental treatments for their loved ones, applaud the new program.

"Some people are going to be healthier. Some people are going to be saved even. It's a life of value what the FDA is doing, it's really a heroic step," Nancy Goodman said.

Nancy Goodman had begged 8 pharmaceutical companies to let her son Jacob try experimental treatments for the brain cancer he was diagnosed with at eight-years-old. Goodman got nowhere and Jacob died when he was ten.

Instead of making doctors plead their case first to companies and then to the FDA if the company agrees to provide the drug, the FDA will become the initial step and will assign a staffer to quickly do the paperwork.

That way, when a company gets a request, it knows the FDA already considers it appropriate

It took Dr. Chul Kim, a lung specialist at Georgetown Lombardi Comprehensive Cancer Center, two months to attempt to get compassionate use for a patient whose cancer was spreading despite usual treatments.

He also believes the program could help many.

"If we speed up the process to be able to access the investigational drug that looks promising I think that can be life-saving for many patients who do not have otherwise good options for treatment," said Kim.

For more information on contacting Project Facilitate, CLICK HERE.

Medical professionals can call 240-402-0004 between 9A-5P Eastern time, Monday to Friday, or email OncProjectFacilitate@fda.hhs.gov to begin the process.
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