Health Committee Republicans Request Details On FDA’s Promotion Of The New Health Care Law

Wednesday, June 19, 2013

All Republican members of the Senate health committee on Wednesday sent a letter to U.S. Food and Drug Administration (FDA) Commissioner Margaret Hamburg requesting details on the agency’s promotion of the new health care law, saying, “The upcoming enrollment period and coverage availability under PPACA appear to be outside of your agency’s mission to approve and regulate lifesaving medical products in a timely manner and keeping our food supply safe."

Senator Lamar Alexander (R-Tn.), the committee’s lead Republican, along with Senators Mike Enzi (R-Wyo.), Richard Burr (R-N.C.), Johnny Isakson (R-Ga.), Rand Paul (R-Ky.), Orrin Hatch (R-Utah), Pat Roberts (R-Kan.), Lisa Murkowski (R-Ak.), Mark Kirk (R-Il.), and Tim Scott (R-S.C.) sent the letter in response to an email alert issued through the FDA’s public email distribution system that promoted open enrollment in the new health insurance exchanges—offering links to a free webinar and promoting the benefits of the law to four different groups: families, individuals, small businesses and clinicians. For example, for clinicians the email detailed “the top five ways you and your practice benefit from the Affordable Care Act.”

The senators wrote: “We are writing to ask why and under what authority the Food and Drug Administration (FDA) is using its time and resources to enroll Americans in health insurance marketplaces created by the new health care law.  On June 3, 2013, the FDA sent a notice to families, individuals, small businesses and clinicians promoting insurance market changes in the new health care law. The e-mail alerts your agency sends to the public should reflect your agency’s actual statutory mission to assure the safety of food, drugs, and medical devices.  The upcoming enrollment period and insurance coverage availability under the new law appear to be outside of your agency’s mission to approve and regulate lifesaving medical products in a timely manner and keeping our food supply safe.”

They added: “In light of the current fiscal environment and recent sequestration, it is especially important to focus scarce resources on FDA’s actual mission. You have said publicly that under the sequester, ‘Clearly we will be able to provide less of the oversight functions and we won't be able to broaden our reach to new facilities either, so inevitably that increases risk.’”

They continued: “While our nation suffers from numerous drug shortages and patients are waiting for drugs and medical device approvals, the FDA should not be using resources designated for these purposes to fund an effort unrelated to your agency’s mission of ‘assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.’ We are also concerned that this is another attempt by the Department of Health and Human Services to avoid congressional limitations on implementation expenditures for the new health care law.”

The full text of the letter is below:

The Honorable Margaret Hamburg

Commissioner

U.S. Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20093

Dear Commissioner Hamburg:

We are writing to ask why and under what authority the Food and Drug Administration (FDA) is using its time and resources to enroll Americans in health insurance marketplaces created by the new health care law.  On June 3, 2013, the FDA sent a notice to families, individuals, small businesses and clinicians promoting insurance market changes in the new health care law. The e-mail alerts your agency sends to the public should reflect your agency’s actual statutory mission to assure the safety of food, drugs, and medical devices.  The upcoming enrollment period and insurance coverage availability under the new law appear to be outside of your agency’s mission to approve and regulate lifesaving medical products in a timely manner and keeping our food supply safe.

In light of the current fiscal environment and recent sequestration, it is especially important to focus scarce resources on FDA’s actual mission. You have said publicly that under the sequester, “Clearly we will be able to provide less of the oversight functions and we won't be able to broaden our reach to new facilities either, so inevitably that increases risk."[1]

While our nation suffers from numerous drug shortages and patients are waiting for drugs and medical device approvals, the FDA should not be using resources designated for these purposes to fund an effort unrelated to your agency’s mission of “assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.”   We are also concerned that this is another attempt by the Department of Health and Human Services to avoid congressional limitations on implementation expenditures for the new health care law. 

For these reasons, we would like to know:

1.       Under what legal authority is your agency promoting implementation of the new health care law and/or insurance coverage?

2.       How do your activities further the mission of the Food and Drug Administration?

3.       In addition to the attached email, what additional activities is FDA undertaking to support implementation of the new healthcare law?

4.       What appropriations account is FDA charging for its costs in supporting implementation of the new healthcare law?

5.       What are the total costs to date and what is the amount allocated for the fiscal year for these activities?

Please respond in writing no later than June 26, 2013.

Sincerely,

Lamar Alexander, Ranking Member

Mike Enzi

Richard Burr

Johnny Isakson

Rand Paul

Orrin Hatch

Pat Roberts

Lisa Murkowski

Mark Kirk

Tim Scott

cc:        The Honorable Daniel Levinson, Inspector General

            The Honorable Gene Dodaro, Comptroller General


Morning Pointe Foundation Partners With YMCA In Dementia Training

The Morning Pointe Foundation hosted an educational training through its REC-FAST aging care partnership with the YMCA of Metropolitan Chattanooga. More than 70 personal trainers, program experts, customer service representatives and leadership from five area YMCAs attended the training in Chattanooga. The foundation established the REC-FAST partnership with a mission to lead ... (click for more)

Erlanger Receives Unanimous Approval From State For Expanded NICU Services

Erlanger Health System received unanimous approval on Wednesday from the Tennessee Health Services and Development Agency for a Certificate of Need (CON) application to expand neonatal intensive care services at both Children’s Hospital at Erlanger, at the main downtown campus, and at Erlanger East Hospital on Gunbarrel Road. The CON approval allows for the establishment of ... (click for more)

Woman, 26, Who Was Set To Testify In Murder Trial, Is Shot And Killed On Elder Street

A 26-year-old woman who was set to testify in an upcoming murder trial was shot multiple times and killed on Wednesday morning. Chattanooga Police responded to the 2100 block of Elder Street on a report of a dead person on the side of the road near Old Ringgold Road and Westside Drive. Police located Bianca Horton.  P olice established a crime scene.  Chattanooga ... (click for more)

Attorney For Bobby Stone Hits Berke, Fletcher For Commenting On Pending Case

The attorney for Bobby Stone on Wednesday said it was "fundamentally wrong" for Mayor Andy Berke and Police Chief Fred Fletcher to comment on the case in which Mr. Stone is charged with domestic assault against his wife, Berke advisor Lacie Stone. Attorney Lee Davis said the comments were unfair and "a disservice to the court." Mayor Berke denied any inappropriate contact ... (click for more)

Case Handled Like Any Other? - And Response

It is interesting that Chief Fletcher would deem the handling of the Mayor's encounter as typical or normal. Is the Chief asking the public to believe that all misdemeanor domestic violence arrests include a 4-hour taped interrogation, and delayed reporting after a visit to the Chief’s house. Of course, we believe that Chief Fletcher. April Eidson * * *  I ... (click for more)

Roy Exum: Christian Schools Bully, Too

Earlier this week, after I shared a story about bullying written by a very brave mother, it opened a floodgate of emails from parents and students who have been forced to endure such madness in our elementary, junior and senior high schools. Discipline is the No. 1 problem in our schools. Because of it, or because of a lack of it, no wonder our children cannot achieve all that ... (click for more)