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12/21/2016

CoA Institute Investigates Red Tape Limiting Access to Zika Testing

Washington D.C. – Cause of Action Institute (“CoA Institute”) today sent a Freedom of Information Act (“FOIA”) request to the Food and Drug Administration (“FDA”) to examine its role in regulating laboratory developed tests (“LDTs”), including tests for the Zika virus. This investigation comes on the heels of the FDA’s post-election decision to indefinitely postpone guidance documents the FDA had issued in an attempt to regulate LDTs. 

This year, the FDA took steps to enforce its guidance against labs that had developed Zika tests. The FDA’s actions would further limit patients’ access to testing for the Zika virus, which can cause serious birth defects. The FDA and the Centers for Disease Control and Prevention (“CDC”) have already put in place a policy limiting the availability of Zika tests to only pregnant women and individuals who were exposed to Zika and are experiencing symptoms. In other words, unless pregnant, an asymptomatic person who has traveled to a country with known Zika transmission prohibited from being tested for the virus. This policy prevents couples who are trying to conceive from information that would help them make personal healthcare and family planning decisions. 

CoA Institute Vice President John Vecchione: “The FDA needs to explain its actions. After 40 years of allowing laboratories to innovate freely and offer patients a variety of tests that often meet unique healthcare needs, it is troubling that the FDA has chosen to crack down just as the Zika virus started to spread. Couples exposed to Zika who are trying to conceive should not have to face bureaucratic hurdles to obtain testing. Instead, they and their doctor should have access to testing services that meet their unique needs. Such decisions cannot be made at a bureaucracy’s pace.” 

Due to the rapid onset and spread of the Zika virus, there is still no test that has undergone the FDA approval process for in vitro laboratory developed tests (meaning laboratory tests performed in a test tube, culture dish, or elsewhere outside a living organism). Rather, the Zika tests currently available for use were all approved by the FDA pursuant to an “Emergency Use Authorization,” which comes with strict limitations.

Clinical laboratories that perform testing services were historically regulated solely by the Centers for Medicare and Medicaid Services. However, beginning in 2014, the FDA asserted that it, too, has regulatory authority over laboratory developed tests. The FDA has authority to regulate manufactured drugs and “medical devices” pursuant to the Federal Food, Drug, and Cosmetic Act. In 2014, the FDA issued draft guidance documents that assert sweeping authority to treat laboratory developed tests as “medical devices.” Accordingly, the FDA asserted authority to regulate LDTs as “medical devices” under this updated guidance.   

In addition to a CDC-developed test, private laboratory companies have developed Zika tests and obtained approval to administer the tests pursuant to the Emergency Use Authorization. However, even these tests developed by private companies are subject to the CDC’s policy limiting the test to pregnant women or symptomatic individuals who were exposed to Zika.     

CoA Institute is interested in learning more about the FDA’s attempts to regulate these tests and the impacts such regulation may have on the ability of patients and doctors to access testing services.

The full FOIA is available here

 

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10/17/2014

The Weekly Standard: The Blame-Deflection Game

Read the full story: The Weekly Standard

The waste is not confined to NIH, either. The Weekly Standard reported last year that the Centers for Disease Control, which presumably should also be fighting Ebola, was using part of its $12.5 billion Obamacare slush fund to campaign for tougher state liquor laws. A 19-month investigation by watchdog Cause of Action concluded the use of these funds violated the law and was “a front for lobbying, government propaganda, and cronyism.”

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03/11/2014

Washington Free Beacon: Federal Support for Anti-Tobacco Advocacy Raises Legal Questions

Read the full story: Washington Free Beacon

The solicitation mentioned “community smoke-free policies” and tax increases on tobacco sales as worthwhile legislative objectives for subgrantees.

 

Dan Epstein, executive director of the government watchdog group Cause of Action, said his group investigated similar allegations of federally funded lobbying efforts financed by Obamacare and the 2009 stimulus bill.

 

COA dug into Centers for Disease Control and Prevention (CDC) grants through its stimulus-funded Communities Putting Prevention to Work program.

 

Ostensibly a “preventative health” project, CPPW “laundered money through so-called stealth lobbying coalitions, formed to skirt prohibitions on lobbying by non-profits, in order to promote local laws banning otherwise legal consumer products such as sodas, e-cigarettes, and fast food,” COA wrote in a report on the program.

 

“We already uncovered multiple organizations around the country that illegally lobbied with federal taxpayer dollars under the Communities Putting Prevention to Work program,” Epstein wrote in an email.

 

“We also know that entities in Missouri that received CPPW money have been offered federal funds by MFH efforts, so it is no surprise that the unchecked grant money going to MFH could now be used to violate the law again,” he said.

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06/3/2013

GAO on CPPW: Nothing to See Here

Arriving in the context of a broader lobbying controversy, the Government Accountability Office (GAO) recently released a report on the Centers for Disease Control and Prevention’s (CDC) lobbying policies. Even by the standards of government investigators, the GAO did a pathetic job examining the degree of CDC oversight of the Communities Putting Prevention to Work (CPPW) program and its award recipients.  It makes more sense to describe GAO’s work as a survey of CDC employees, rather than as an independent evaluative report.

In responding to requests for information from Senators Lamar Alexander (R-TN), Tom Coburn (R-OK), Susan Collins (R-ME), and Orrin Hatch (R-UT), the GAO reviewed:

[D]ocuments provided by CDC, including the written policy on lobbying that pertained to CPPW award recipients; CPPW award notices, which were the written agreements between the CDC and recipients; documentation generated by CDC staff during the monitoring of CPPW recipients; and CDC site visit reports.

The GAO also interviewed CDC officials regarding the lobbying policy that applied to CPPW award recipients in two hundred eighty CPPW cooperative agreements, all of which were made in fiscal year 2010.

But just over six weeks ago, Cause of Action (CoA) released its own report, “CPPW: Putting Politics to Work,” examining twelve grant recipients based on responses to FOIA requests we sent to the CDC. Of those twelve, eight appeared to use federal funds to illegally lobby for things like tobacco taxes, clean air ordinances, and bans on sugary-sweetened drinks, rather than on sensible preventative health efforts.

CoA’s report also demonstrated that the CDC failed to take comprehensive action in one case of illegal lobbying it actually managed to identify.  While the GAO had access to information on all grant recipients and considered two potential lobbying violations identified by the CDC, CoA continues to await more information from the CDC on the other grant recipients. If we found that eight of the twelve we have been able to investigate up to this point are at risk of violating federal law, how many more instances are out there that the GAO and CDC have failed to uncover?

Unfortunately, the GAO’s report was not a substantive investigation. In fact, the most noteworthy aspect of the GAO report is how sparingly the GAO examined the CDC’s ability to follow-through on its own processes for correcting instances of illegal lobbying by grantees.  Instead, the GAO confirmed that the CDC engaged in no active audit function for the CPPW program, could not independently verify subrecipient expenses, and depended on self-reporting by grantees.

These findings are particularly troubling because, as the GAO fails to mention in its report, by 2015 the Department of Health and Human Services will be able to spend $2 billion per year in perpetuity on similar programs through the Affordable Care Act’s Prevention and Public Health Fund.

 

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04/16/2013

Cronies Putting Politics to Work

The Communities Putting Prevention to Work (CPPW) program is a grant program administered by the CDC for education on tobacco use and obesity prevention.   All grant recipients are notified that it is illegal to use the funds for lobbying, but a CoA investigation has uncovered seven new instances where your federal tax dollars were used to push for higher taxes and new ordinances. Our investigation shows how the CDC failed to conduct proper oversight of the CPPW program. While the CDC was made aware of the Florence County, SC violation, CoA uncovered seven additional communities in risk of violating federal law and HHS guidelines.

Read more in our Press Release or see the full report here. 

Florence County, SC

$6 million for tobacco control

 Illegal Lobbying 

  • The South Carolina Department of Health and Environmental Control (DHEC) and the Smoke Free Florence (SFF) coalition used the grant money to lobby in support of a smoke-free ordinance.
    • This email from a DHEC employee describes lobbying  two members of the county commission (Glynn and Buddy): 

 Cover-up

  • CPPW staff at DHEC attempted to cover-up the lobbying by altering the meeting minutes.
    • “DHEC would like to go through the past meeting minutes to “massage” them and take out the details.”
    • “He said that it is not unethical because they are not looking to “twist” things that were written, just remove the details.”

Pima County, AZ

$15.8 million for obesity prevention 

  • The Pima County Health Department (PCHD) used taxpayer dollars to contract with the University of Arizona to lead policy workshops and develop neighborhood plans in support of zoning codes, regulations, and ordinances.

Out in the Open

  • The sub-contract for the University of Arizona College Of Architecture clearly states that the grantee will be “engaging public officials.”  

Jefferson County, AL

$13.3 million for tobacco control and obesity prevention

  • CPPW funds paid 80% of the salary for a “Director of Advocacy” with the following duties and responsibilities: 

Miami-Dade County, FL

$14.7 million for obesity prevention 

  • The Miami-Dade County Health Department (MDCHD) used taxpayer funds to hire the Health Council of South Florida to provide a legislative agenda for CPPW-funded policy work.

Mobile County, AL

$2.4 million for obesity prevention 

  • CPPW funds paid the salary of an “outreach coordinator” who worked with the TFMC to “educate decision makers about the benefit of 100% percent smoke-free policy, increasing the unit price of tobacco products, and reducing tobacco advertising. 

Los Angeles County, CA

$32.1 million for tobacco control and obesity prevention

  • LA Public Health used CPPW funds to  hire a “Legislated Policy Project Coordinator” who managed teams of policy liaisons, community organizers and community representatives

 Santa Clara County, CA

$6.9 million for tobacco control

  • The Santa Clara County Public Health Department (Santa Clara Health) used tax dollars to hire a tobacco retail license coordinator to lobby for a workplace smoking ordinance and also used CPPW funds to support a state-wide tobacco tax increase.

DeKalb County, GA

$3.2 million for tobacco control and obesity prevention

  • The DeKalb County Board of Health (DCBH) used CPPW funds to support the adoption of a strengthened county CIAO and partnered with the Georgia Alliance for Tobacco Prevention (GA Alliance) to train coalition partners and finance a media campaign in support of state cigarette tax increase.

 

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04/16/2013

REPORT: CPPW: Putting Politics to Work

Final CPPW Report

CPPW Final Exhibits PDF

 

I.                  Executive Summary

 

Since 2009, Congress has appropriated $373 million to the Centers for Disease Control and Prevention (CDC) for the Communities Putting Prevention to Work (CPPW) program.  The goal of CPPW is to educate the public about obesity prevention and the dangers of tobacco use.  Despite this noble goal, Cause of Action’s (CoA) nineteen month-long investigation shows that at least seven communities that received CPPW funds violated federal law, as well as CDC guidelines, by using taxpayer dollars to lobby for higher taxes and new local laws.

Although Congress conducted hearings in 2011 to question the CDC’s oversight of the program and followed up with letters to Department of Health and Human Services (HHS) Secretary Kathleen Sebelius in 2012, these questions only addressed one potential violation in one community in South Carolina.  CoA found seven other potential violations of the CPPW program that have not been public until now, and learned that the CDC’s one recorded violation was worse than disclosed.

The CPPW program was intended for public education and job creation as part of the American Recovery and Reinvestment Act of 2009 (ARRA).  CoA’s investigation revealed that CPPW money went to support lobbyists and public relations companies who used taxpayer dollars to push laws and agendas that would lead to tax increases on tobacco and high calorie products – essentially transforming the CPPW program into a conduit for lobbying for higher taxes and bans on otherwise legal consumer products.

CoA uncovered evidence of seven different communities around the country using CPPW money to lobby in violation of federal law and CDC policy.  These warrant investigation, review, and accountability, especially in light of the $2 billion in annual funding scheduled for disbursement in 2015 under the 2010 Patient Protection and Affordable Care Act’s Community Transformation Grants program to fight obesity and tobacco use at the local, state, and federal level.  The HHS, the federal agency that oversees the CDC, is also the largest grant-issuing agency in the federal government.

The following report reveals how the CDC permitted and even encouraged CPPW grantees in Arizona, Alabama, Florida, Georgia, and California to violate federal law and use CPPW funds to lobby state and local governments.   Internal emails, applications to the CDC outlining plans for the funds, and meeting notes blatantly show systemic corruption and use of taxpayer dollars for lobbying.

CoA found that lobbying by CPPW grant recipients violates the following four laws and guidelines:

  1. The Anti-Lobbying Act prohibits the use of money appropriated by Congress to influence, “an official of any government, to favor, adopt, or oppose, by vote or otherwise, any legislation, law, ratification, policy, or appropriation.”
  2. The CDC issued additional guidance prohibiting CPPW funds from lobbying use.  Known as Additional Requirement 12 (AR-12) in the CDC’s guidelines, this rule “specifically [applies] to lobbying related to any proposed, pending, or future Federal, state, or local tax increase, or any proposed, pending, or future requirement or restriction on any legal consumer product.”
  3. In 2012, Congress included language in an appropriations bill to clarify that CPPW funds were prohibited from “any activity to advocate or promote any proposed, pending, or future Federal, State, or local tax increase, or any proposed, pending, or future requirement or restriction on any legal consumer product.”
  4. Office of Management and Budget Circular A-122 prohibits the use of federal funds to attempt to influence federal or state legislation through “communication with any member or employee of the Congress or State legislature” or “by preparing, distributing, or using publicity or propaganda, or by urging members of the general public or any segment thereof to contribute to or participate in any mass demonstration, march, rally, fundraising drive, lobbying campaign, or letter writing or telephone campaign.”

South Carolina: A Case Study in Corruption

In addition to the previously mentioned five states, the CPPW pattern of corruption can most easily be traced through the example of South Carolina.

Direct use of federal funds to lobby

As revealed by communications between local officials and the CDC, funds from a CPPW grant to the South Carolina Department of Health and Environmental Control (DHEC) were used to illegally lobby city council members in support of a pending local smoke-free ordinance, proof of direct illegal lobbying with CPPW funds.

Stealth lobbying by coalitions to avoid legal oversight

The Smoke Free Florence (SFF) coalition is a group of like-minded organizations that formed to lobby for the causes outlined in DHEC’s CPPW grant application, and yet, by design, the SFF evades regulations that apply to lobbyists.  Known as stealth lobbying, this approach is one way to avoid lobbying rules but still, in effect, conduct lobbying while receiving federal dollars.

CDC failure to properly oversee the use of grant funds

In its review of South Carolina’s grant application from Florence County, which includes a proposal to hire a coordinator “to promote comprehensive smoke-free policies/ordinances throughout the county,” the CDC failed to prohibit lobbying activity, and in fact sent a CDC grants officer to local community meetings where this officer announced that securing a comprehensive smoke-free ordinance was “the number one priority with the [SFF] initiative and 100% adoption will be the determining factor” of success.  While the CDC later reprimanded the South Carolina recipients for their misuse of funds, they largely ignored that meeting minutes were scrubbed to change the appearance of impropriety, raising other potential legal issues outside of improper lobbying.

This report evidences a complete failure of an HHS grant program to adhere to the law, use taxpayer dollars responsibly, or secure jobs it was intended to create.  What follows are numerous examples of counties and states across the country advocating, planning, and supporting legislation in direct violation of federal law and CDC guidelines.  The clock is ticking toward 2015, when $2 billion more will be allocated to similar programs.  This report only begins to document the extent of waste, fraud, and abuse within CPPW, as CoA is still awaiting copious amounts of documents from both the CDC and HHS Office of Inspector General.  The systemic pattern of misfeasance among grantees will end only when the CDC acts responsibly on behalf of the American taxpayers who have become the biggest losers in the government’s campaign to end obesity.

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