FDA Issues Final Rule to Clarify Patient Access to Experimental Drugs

In an effort to broaden and clarify access by individual patients to experimental medicines that have not yet obtained FDA approval or haven’t been approved for a new use, the Food and Drug Administration issued two new rules on August 12, 2009.

• The Expanded Access rule establishes how seriously ill individual patients or groups of patients can obtain investigational medicines while at the same time preserving the clinical trials process.
• The Charging rule clarifies when a manufacturer of an investigational drug may charge for it and what costs can be recovered in those charges.

In addition, the FDA established a website for consumers to explain access to investigational drugs through clinical trials or through the expanded access process. Continue reading…

Posted by Kate Murphy on August 18th, 2009
Posted in: Research & Treatment News | No Comments »
Tags: compassionate use, expanded access, FDA

FDA Sets Limits on Darvon and Darvocet but Doesn’t Recommend Market Withdrawal

Despite recommendations from two of its advisory committees for a phased withdrawal of propoxyphene-containing products, the Food and Drug Administration won’t be taking them off the market.  Instead they’ll require a black box warning on the label and a medication guide for patients letting them know of the serious risks of death from effects on the heart or overdose.

Best known by brand names Darvon® and Darvocet®, the pain medicines have a high risk for fatal overdose when not used as prescribed.  Opiates, they are prescribed for mild to moderate pain.  However, the FDA says that benefits of the medicines when taken at recommended doses outweigh risks at this time. Continue reading…

Posted by Kate Murphy on August 7th, 2009
Posted in: Uncategorized | No Comments »
Tags: Darvon, FDA, propoxyphene

Colorectal Cancer News in Brief: July 25

Photo by Anna Knott

Research shows how lemon and lavender ease stress by acting on the immune system and gene expression. In colon cancer, patients with lots of immune-system cells in their tumors have better survival, and men and younger people risk more severe Erbitux rash.

In other headlines, FDA warns about toxic chemicals in electronic cigarettes.  Save  August 29th to walk across the Big Dam in Little Rock, Arkansas with the Colon Club. Continue reading…

Posted by Kate Murphy on July 25th, 2009
Posted in: Research & Treatment News | No Comments »
Tags: e-cigarettes, FDA

FDA Approves Labeling Changes for Erbitux and Vectibix to Reflect KRAS Status

The Food and Drug Administration (FDA) has approved labeling changes for Vectibix and Erbitux to reflect studies that found the two drugs are not effective in patients whose tumors have mutated KRAS.

The FDA has updated the indication and usage for Vectibix™  (panitumumab) and Erbitux® (cetuximab) to include a statement that:

Retrospective subset analyses of metastatic or advanced colorectal cancer trials have not shown a treatment benefit for ERBITUX or VECTIBIX in patients whose tumors had K-ras mutations in codon 12 or 13 and that the use of ERBITUX or VECTIBIX is not recommended for the treatment of colorectal cancer with these mutations. Continue reading…

Posted by Kate Murphy on July 21st, 2009
Posted in: Research & Treatment News | No Comments »
Tags: Erbitux, FDA, KRAS, Vectibix

C3 Comments on Transparency at the FDA

An FDA task force has been formed to examine transparency at the Food and Drug Administration (FDA). “President Obama has pledged to strengthen our democracy by creating an unprecedented level of openness and public participation in government, and the FDA looks forward to participating in this process,” said FDA Commissioner Margaret A. Hamburg, M.D. “I have asked the Transparency Task Force to deliver recommendations to me for ways to make more information available and foster better understanding of decision-making.”

One public meeting has been held, and a request for public comments has been posted. C3 provided comments urging FDA to review transparency requirements to ensure that the public is given accurate information both pre- and post-approval. Continue reading…

Posted by Joe Arite on July 1st, 2009
Posted in: Policy & Advocacy News | No Comments »
Tags: Drug Development, FDA