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Higgins Says Testimony by WNY Families Moved FDA Panel to Recommend Changes in the Way Addictive Painkillers are Prescribed

Press Release

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Congressman Brian Higgins (NY-26) applauded the work of local families fighting to address the prescription drug epidemic. Late last week three Western New Yorkers testified at a hearing of the U.S. Food and Drug Administration's (FDA) Drug Safety and Risk Management Advisory Committee. After hearing their stories and other compelling evidence, the panel voted 19-10 to call for stricter controls on the prescription of highly addictive hydrocodone medications. Congressman Higgins wrote a letter to the FDA Commissioner urging the FDA to uphold that recommendation.

"Statistics are often abstract and intangible, but these Western New Yorkers have put a human face on the prescription drug epidemic through their difficult stories detailing the devastation and loss exacted on families as a result of addictive pain killers," said Congressman Higgins. "The work of these families exemplifies the power of people to influence policy."

In his testimony Avi Israel, a Buffalo resident who lost his son Michael David Israel and founded "Save the Michaels of the World" said, "Our society does not want any addicts, but the question is "how did they get to be addicted?"… By following doctors' orders…. You are not denying access or keeping those in need from getting pain relief, you are stopping addiction from starting. It's time to put the face in front of the dollar. It's time to stop the misinformation. It's time to put an end to senseless deaths. Now is the time to move hydrocodone to schedule II."

Also joining Avi in presenting testimony was Buffalo resident Tricia McDonald, mother of Adrianne, as well as Cheryl Placek, a Niagara Falls resident, who lost her son Daniel Jr., a U.S. Navy Veteran.

Under the Controlled Substances Act, substances falling under the Schedule II category have a high potential for abuse which may lead to severe psychological or physical dependence whereas substances categorized under Schedule III drugs are defined as having a moderate to low potential for physical and psychological dependence.

Higgins pointed out that the change would not prevent patients who need these drugs from receiving medication from their doctor; instead it requires safeguards to prescribing clinicians and pharmacists to prevent over-prescription and abuse.

The FDA hearings were being held in response to the Drug Enforcement Administration's (DEA) request for increased regulation of combined hydrocodone drugs in response to their demonstrated potential for addiction. In July of this past year, as planning for these hearings was underway, Higgins wrote to the FDA asking that the hearings include significant public participation so that Save the Michaels of the World could have the opportunity to testify.

The FDA will now review the Advisory Committee's recommendation and make a final recommendation to the U.S. Health and Human Services Secretary, who will make the final decision.

Next week, Avi Israel will be among five Western New Yorkers returning to Washington, DC for a FDA public meeting on the Impact of Approved Drug Labeling on Chronic Opioid Therapy as they continue to be the voice for their loved ones and other families impacted by prescription drug tragedies. Members of the public are also invited to register their opinion with the FDA via email or written comments until April 8, 2013. For more information visit:

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