FDA 'WARNS' ADHD DRUGMAKERS — AGAIN

RECENT TV ADS AND PROMOTIONAL MATERIALS FOR ADHD DRUGS, INCLUDING STRATTERA, CONCERTA & ADDERALL ARE 'DECEPTIVE, FALSE, OR MISLEADING," ACCORDING TO A GOVERNMENT ACTION SPURRED ON BY A CONSUMER LAWSUIT. THE FDA SAYS THAT ALL OF THE ADHD DRUGS BEING ADVERTISED — INCLUDING CELEBRITY TY PENNINGTON'S ENDORSEMENT OF STRATTERA AS A 'TRANSFORMATIONAL' DRUG — "OVERSTATE THE SAFETY AND EFFECTIVENESS" OF STIMULANT DRUGS.

WASHINGTON -(Dow Jones)- The Food and Drug Administration said Friday certain advertisements and other promotional materials for attention-deficit disorder drugs like Adderall, Concerta and Strattera were misleading and omitted important safety information.

The agency sent formal warning letters to Eli Lilly & Co. (LLY), the maker of Strattera, and a U.S. unit of Shire Pharmaceuticals Group PLC (SHPGY), which makes Adderall, telling the firms to immediately stop disseminating "false or misleading" material about the drugs, which are approved to treat attention deficit/hyperactivity disorder, or ADHD. The agency also sent three so-called untitled letters to Johnson & Johnson (JNJ), which makes Concerta, and to two other ADHD drug makers. All of the letters were posted to the FDA's Web site Friday.

Warning letters are considered more serious and allow the agency to take regulatory action such as seizing products if companies do not comply with FDA requests. Most companies address concerns raised by the FDA without the agency taking additional action.

In Shire's case, the FDA said some material on Adderall's Web page as well as a YouTube video featuring celebrity Ty Pennington was misleading. The agency said the Web page and the video "raise significant public health and safety concerns" because they overstated the drug's effectiveness and omitted important safety information.

For example, the video showed Pennington stating Adderall changed his life and that the drug was "truly a transformation."
The FDA said "this video overstates the efficacy of Adderall XR by implying that this product will transform patients' lives and improve their confidence." The agency also said Shire violated FDA regulations for not submitting the YouTube video to the agency prior to using the video.

In a statement, Shire said the video was posted in error and was meant to be posted on Shire's site with the appropriate dosing and indication information for Adderall. "We are committed to complying with both the letter and the spirit of the FDA regulations in the promotion of our medicines," the company said.

Eli Lilly received a warning letter for Strattera after the agency reviewed material used by sales representatives. The agency said the material overstates how effective Strattera is, omits material facts and minimizes important risks associated with Strattera.

"These violations are concerning from a public health perspective because they suggest that Strattera is safer and more effective than has been demonstrated," the agency said in the letter.

A Johnson & Johnson spokeswoman said the company would "work closely with the FDA" to address issues raised in its letter. A request for comment left late Friday with a Lilly representative was not returned.