APA Urges FDA To Rely On Science, Not Anecdote Alone, For Regulating ADHD Drugs

Main Category: ADHD
Also Included In: Psychology / Psychiatry
Article Date: 23 Mar 2006 - 0:00 PDT

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In testimony today, the American Psychiatric Association (APA) told the Food and Drug Administration (FDA) that more research is needed in the area of attention-deficit/hyperactivity disorder (ADHD) and rare adverse events.

Research has already shown ADHD to be highly prevalent and treatments for it to be indisputably effective. But rare adverse events associated with stimulants used to treat ADHD - medications that have been around for more than 50 years - have been the subject of two recent FDA hearings, including today's. Such events warrant accelerated research and an appropriate regulatory response based on scientific evidence. Any FDA regulatory action that results in restricted access to treatment could do more harm than good.

"We know that appropriate intervention for ADHD actually saves lives," testified David Fassler, M.D., a Vermont-based child and adolescent psychiatrist who is also an APA trustee-at-large. "Specifically, treatment reduces the risk of serious accidents, including accidents which lead to head injury and permanent disability. Research also demonstrates that treatment significantly reduces the risk of substance abuse in adolescents."

The previous FDA hearing, held on February 9, resulted in an abrupt recommendation, on an 8-7-1 vote, that the agency issue a "black box" warning on the medications - an action that even some panel members acknowledged was beyond the scope of their mission and is unsupported by clear evidence at this time. The previous panel's purpose, according to the FDA, was "to discuss approaches that could be used to study whether these [ADHD medication] products increase the risk of adverse cardiovascular outcomes."

Today's panel, the Pediatric Advisory Committee, will have its own opportunity to advise the FDA on what action, if any, should be taken.

APA Research Director Darrel A. Regier, M.D., M.P.H., said the basis for a black box warning should be a medication's potential dangers, not an FDA consultant's personal opinion about what ADHD's appropriate level of prevalence and treatment is.

"We urge the FDA to avoid the use of black box warnings as expressions of personal opinions about allegations of inappropriate prescribing," testified Dr. Regier. "The risks of limiting access to valid and effective treatments clearly is heightened when the FDA is asked to use non-research standards for warnings. In this context, the plural of anecdote is not data."

The APA made several recommendations to policymakers in its statements:

-- Support large scale, multi-site studies with long-term follow up;

-- With respect to MedGuides, present any information about potential risks in a balanced context, with appropriate information about efficacy and the benefits of treatment;

-- Put as much information as possible into the hands of physicians, parents and patients about all medications, not only those used in treating ADHD;

-- With respect to monitoring, avoid mandating specific schedules unless data is available clearly demonstrating a positive impact on outcome. Frequency of ongoing contact should be based on the clinical needs of the patient;

-- And, help ensure implementation of best practice treatment guidelines for ADHD.

To see the full text of Dr. Fassler's statement, follow this link.

To see the full text of Dr. Regier's statement, follow this link.

About the American Psychiatric Association

The American Psychiatric Association is a national medical specialty society whose more than 36,000 physician members specialize in diagnosis, treatment, prevention and research of mental illnesses including substance use disorders.

Visit the APA at www.psych.org and www.healthyminds.org.

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