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


Blood Assurance Makes Schedule Changes Due To Threat Of Inclement Weather

The threat of inclement weather across our region has led Blood Assurance to make changes to its schedule for this  Thursday . Blood Assurance donor centers and bloodmobiles are adjusting their hours of operation so team members and donors can arrive safely. The donor centers in Hixson, Johnson City, Cleveland, Downtown Chattanooga, East Brainerd, Dalton, Fort Oglethorpe, ... (click for more)

Fred's Super Dollar Stores Raise Money For Children's Miracle Network Hospitals

Fred’s Super Dollar stores have kicked off their 10th year raising funds Children’s Miracle Network Hospitals. Fred’s customers and team members are once again supporting patients treated at Children’s Hospital at Erlanger during the Children’s Miracle Network Hospitals Miracle Balloon fundraiser.   Funds raised now through  April 5  will provide medical ... (click for more)

Winter Weather Advisory Goes Into Effect At 4 A.M. On Thursday; Hamilton County Schools On 2-Hour Delay

Temperatures were mild on Wednesday, but they were set to drop as the day goes on - leading to a winter weather advisory. The advisory goes into effect at 4 a.m. on Thursday and is to continue until 4 p.m. The forecast is for freezing rain, sleet and snow with accumulations of two inches or less. Hamilton County Schools will be on two-hour delay on Thursday . School officials ... (click for more)

County Commission Votes 5-4 In Favor of Middle Valley Neighborhood Walmart

The County Commission on Wednesday voted 5-4 to allow a Walmart Neighborhood Center at Middle Valley Road and Thrasher Pike. Voting in favor were Jim Fields, Chester Bankston, Greg Beck, Warren Mackey and Joe Graham. Opposed were Marty Haynes, Sabrena Smedley, Tim Boyd and Randy Fairbanks. Commissioner Haynes, the District 3 representative where the project is located, ... (click for more)

Women Don't Ask For Rape, They Ask For Justice

The stereotypical irrationality that women typically lie about rape has brought an enormous amount of social stigma to this population. Many like to think that rape is not a huge issue in the United States, and that the media blows it out of proportion. The Federal Bureau of Investigation (FBI) reported that approximately 17.7 million females in America have been raped, with 108,612 ... (click for more)

Roy Exum: Happy Birthday, Mr. Berg

This past Monday we should have closed the Post Office, let kids out of school, and lowered our flags to half-mast. March 2 is the anniversary of Moe Berg’s birthday and the legendary Casey Stengel once said Moe was “the strangest man ever to play baseball.” Moe played major league baseball for 16 years, finishing with the Boston Red Sox in 1939 and a lifetime batting average of ... (click for more)