Dingell Urges Congressional Hearings on Fungal Meningitis Outbreak

Washington, D.C. –  Congressman John D. Dingell (D-MI15), an author of the recently enacted Food and Drug Administration Safety and Innovation Act,  is urging House Committee on Energy and Commerce Chairman, Representative Fred Upton (R-MI), to hold Congressional hearings immediately upon Congress’ return in November on the recent fungal meningitis outbreak caused by contaminated pharmaceuticals supplied by New England Compounding Center (NECC).  In addition to the fungal meningitis outbreak, Dingell is also calling on Congress to request further information in regard to the announcement made by the U.S. Food and Drug Administration (FDA) that other NECC products are sickening patients.

It was reported early last week that NECC had been supplying hospitals and clinics across the country with contaminated pharmaceuticals used for steroid injections.  Health officials at the FDA now believe there is a possibility the outbreak of meningitis could include other types of infections in patients who have been treated during eye operations and open-heart surgeries.  Michigan alone has seen 46 sickened and 3 deaths due to this outbreak, and remains having the second largest concentration of cases nationwide.  

“As FDA’s investigation continues to uncover more devastating news, we must do our part to determine the cause and cure of this outbreak,” said Dingell.  “I urge my colleagues on the Committee to examine current policy issues surrounding this crisis to prevent another one from happening in the future.”

Should the Committee find additional federal authorities warranted, Dingell is calling for a bipartisan legislative solution that would continue to keep our food and drug supply safe.   

The text of the letter is below and a copy can be viewed here.

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October 17, 2012

The Honorable Fred Upton

Chairman

Committee on Energy and Commerce

2125 Rayburn House Office Building

Washington, D.C. 20515

Dear Chairman Upton:

            I write to you today to urge that the Committee hold hearings on the ongoing fungal meningitis outbreak caused by a epidural steroid injections, as well as the recent announcement by the U.S. Food and Drug Administration (FDA) that other products produced by the New England Compounding Center (NECC) are also sickening patients.  As you well know, our home state of Michigan has the second highest number of patients impacted by these contaminated products, and this outbreak only continues to spread throughout the Nation.

            Thus far, contaminated methylprednisolone acetate produced by NECC has sickened 233 patients and resulted in 15 deaths in 15 states.  CDC has noted that up to 14,000 patients in 23 states may have been exposed to this steroid.  Further, It is still unclear how many patients may have been exposed to other contaminated products made by NECC, which underscores the need for the Committee to hold hearings with all due speed.

            I happen to believe that compounding pharmacies do serve a public health need when they are operating in the traditional sense – providing individual patients with the drug products needed to suit their unique needs.  However, this case has shown that not all compounding pharmacies are operating in this manner.  It is clear to me that NECC was acting as a drug manufacturer under the guise of compounding pharmacy.  NECC produced over 17,000 vials of the steroid thought to be at the root of the fungal meningitis outbreak without individual patient prescriptions as required under state regulations, shipped to 76 different facilities in 23 states, and has even reportedly solicited bulk orders from health providers.  Both FDA and state boards of pharmacies are the regulatory bodies responsible for overseeing compounding pharmacies, and yet NECC flagrantly ignored warning letters by FDA and its own state regulations.  Though the investigation around this particular outbreak by FDA, the Centers for Disease Control and Prevention (CDC), and the Massachusetts Department of Public Health is still ongoing, it is critical that the Committee must examine the policy issues surrounding this case to ensure that it does not happen again.

           A hearing would help this Committee to better determine the causes of the outbreak, as well as the cures, and I urge you to schedule hearings immediately when Congress is back in session this November.  Further, I ask that we work in a bipartisan manner on legislation that will ensure the continued safety of our drug supply, should our Committee investigation find that additional federal authorities are warranted.

With every good wish,

                                                            Sincerely,

                                                            John D. Dingell

                                                            Member of Congress

cc:       The Honorable Henry Waxman, Ranking Member

            Committee on Energy and Commerce

            The Honorable Joseph R. Pitts, Chairman

            Committee on Energy and Commerce

                        Subcommittee on Health

            The Honorable Frank Pallone, Jr., Ranking Member

            Committee on Energy and Commerce

                        Subcommittee on Health

            The Honorable Cliff Stearns, Chairman

            Committee on Energy and Commerce

                        Subcommittee on Oversight and Investigations

            The Honorable Diana DeGette, Ranking Member

            Committee on Energy and Commerce

                        Subcommittee on Oversight and Investigations