AASLD and Advocacy: Sometimes it Takes Awhile

AASLD and Advocacy: Sometimes it Takes Awhile

By Lyle Dennis, Cavarocchi – Ruscio – Dennis Associates, Consultants to AASLD

It is axiomatic that the wheels of government turn slowly. Sometimes, we see that they do not turn at all! But when government acts and acts in the interest of your patients as result of AASLD’s efforts, it is important that you know about it. Recently, two examples have come across our desk (or more accurately our computer screen) that are worth mentioning.

The FDA and Acetaminophen

A couple of years ago, the three FDA advisory committees held a joint hearing to discuss the role of acetaminophen in liver toxicity. Acetaminophen is, of course, one of the safest drugs on the market when used appropriately, following label directions. However, sometimes people assume that more is better or they don’t realize that it is included in other pain-relieving drugs. In that way, patients can get into trouble and the trouble is usually directly felt in the liver.

The FDA considered multiple options for reducing the possibility of inadvertent overdose of acetaminophen. AASLD was an active participant in the process. Dr. Tim Davern testified on AASLD’s behalf; Dr. Will Lee was an expert advisor to the FDA. AASLD sought aggressive action from the FDA to reduce risk to patients.

While we certainly did not get all we asked for in the hearing, the FDA eventually did adopt some additional restrictions on acetaminophen. Among them was limiting its presence in prescriptions medicines to 325 mg or lower, the equivalent of a single regular strength OTC pill.

Last month, the FDA approved a new formulation for Vicodin® that contains 300 mg of acetaminophen – the lowest effective dose of the pain reliever in combination hydrocodone products. It is going on the market more than a year before the FDA deadline and revised packaging will communicate the new levels to doctors, pharmacists, and patients.

This is one step in addressing a significant and complicated problem, but it seems clear that AASLD’s experts like Drs. Davern and Lee played a significant role in moving this cause forward.

The Viral Hepatitis Action Plan

Regular readers know the sequence of events that led to the Department of Health and Human Services (HHS) adopting an action plan to address viral hepatitis in May 2011. First, an Institute of Medicine Report on the problem; then AASLD and the Trust for America’s Health combined to issue a blueprint for addressing this issue; then the Action Plan was issued by the Office of the Assistant Secretary for Health Dr. Howard Koh.

Recently, HHS issued the Interagency Implementation Progress Report – Year 1 and it is full of hopeful and helpful information. Implementation is proceeding apace in fifteen HHS agencies, as well as in the Federal Bureau of Prisons and the Department of Veterans Affairs

This report highlights the progress that has been made in the first year since the plan was adopted.

If you click on the link above and read the report, you will find a stunning level of cooperation among government agencies that have not always played nicely in the sandbox together. As you read it, you can be proud to know that AASLD was involved with creating this report, working on the ground floor with the Assistant Secretary for Health and the with the CDC to make it a reality.

These are just two recent examples among many where aggressive advocacy on the part of AASLD, its leadership, and its members has resulted in moving the proverbial needle on government action.  http://www.aasld.org/news/110112/Pages/default.aspx