Washington, DC — Ledyard King reports in USA Today that, until now, drug companies have been free to decide whether to pursue treatments for pediatric cancers as part of their work on adult cancers.
They won’t have much choice going forward.
The Senate on August 3 overwhelmingly passed legislation requiring the pharmaceutical industry to expend more resources on treatment for childhood cancers.
The bill, part of a larger measure reauthorizing user fees imposed by the Food and Drug Administration (FDA), heads to President Donald J. Trump for his expected signature.
They won’t have much choice going forward.
The Senate on August 3 overwhelmingly passed legislation requiring the pharmaceutical industry to expend more resources on treatment for childhood cancers.
The bill, part of a larger measure reauthorizing user fees imposed by the Food and Drug Administration (FDA), heads to President Donald J. Trump for his expected signature.
Existing law directs companies to study the safety and efficacy of adult drugs on children unless the FDA gives them a waiver. Medicine developed to treat heart disease or diabates for adults, for example, must also be tested for its use on children.
But when it comes to cancer, advocates say the FDA has too much latitude to exempt the industry from studying and developing help for kids.
Federal regulators often have not required companies that invest heavily in the four major cancers — breast, prostate, lung and colon — to research how the treatments they develop for those adult-oriented diseases might assist in addressing childhood cancers.
Over the past 20 years, the FDA has approved about 190 new cancer treatments for adults but only three for children, said Sen. Michael Bennet, a Colorado Democrat who co-sponsored the provision with Florida Republican Sen. Marco Rubio.
For King’s full story, click here.
But when it comes to cancer, advocates say the FDA has too much latitude to exempt the industry from studying and developing help for kids.
Federal regulators often have not required companies that invest heavily in the four major cancers — breast, prostate, lung and colon — to research how the treatments they develop for those adult-oriented diseases might assist in addressing childhood cancers.
Over the past 20 years, the FDA has approved about 190 new cancer treatments for adults but only three for children, said Sen. Michael Bennet, a Colorado Democrat who co-sponsored the provision with Florida Republican Sen. Marco Rubio.
For King’s full story, click here.
