Fixing the FDA: Options for the Next President

The last several years have not been kind to the Food and Drug Administration (FDA). Critics have accused the agency of being inefficient, failing to meet its mandates and of complicity with the pharmaceutical industry. The FDA has come under attack by Congress, health and medical professionals and the pharmaceutical, tobacco and food industries. One director was forced to quit and the current director has repeatedly been summoned by Congressional committees to respond to criticisms.

With the 2008 presidential election quickly approaching, the topic of health care, including the safety of pharmaceuticals, has gained increasing attention. The next United States President will face great pressure to reform the FDA and will need to simultaneously attend to issues of efficiency, drug and food safety, tobacco and funding. How the President and Congress choose to respond to industry calls to make the FDA even more business friendly and advocates calls for restoring the FDA’s public health mandates will shape how a key federal agency will regulate corporate practices that influence health in the next four years.

This Corporations and Health Watch story begins a series examining recent conflicts about the FDA, the positions of the presidential candidates on the agency and options for 2009 and beyond. This report’s focus is on the FDA and the pharmaceutical industry. Future reports will examine the role of the FDA in regulating food and tobacco.

Drug Safety


The FDA’s recent troubles with Vioxx, Avandia and Heparin illustrate the range of problems the agency faces in premarket testing, oversight of foreign industries and on limiting industry influence on its decisions. In Fall of 2004, pharmaceutical giant Merck began the largest and most expensive drug recall in history by pulling its drug Vioxx off the market after studies showed that chronic use was associated with an increased risk of heart attacks and strokes. Approved in 1999 based on data submitted to the FDA but not reviewed through the standard scientific peer review, Vioxx is reported to have caused as many as 139,000 heart attacks.1

Although Merck was initially praised for its voluntary withdrawal of the product, critics later charged that Merck had known about the risks involved with long-term use far earlier than it had gone public with them.1 Merck was eventually shown to have ignored research published three years earlier, which found that long-term Vioxx use increased risk of cardiovascular events, and to have planted studies in medical journals that were attributed to independent researchers.2 Whistleblower and 20 year employee of the FDA David Graham later testified that the agency’s role in the Vioxx scandal was far from innocent, stating: “What happened with Vioxx is really a symptom of something far more dangerous to the safety of the American people. Simply put, the FDA and its Center for Drug Evaluation and Research are broken.”1


In June 2007, the New England Journal of Medicine published a meta analysis of 42 clinical trials for Avandia that showed that the drug was associated with increased risk of myocardial ischemic events.3 It wasn’t until five months later that the FDA announced additional warnings on the Avandia product label. In addition, an advisory committee voted to keep the product on the market despite a later study published in the Journal of the American Medical Association which concluded that Avandia was associated with increased risk of acute myocardial infarction, congestive heart failures and mortality in older patients undergoing diabetes treatment.4


Earlier this year, the FDA was criticized for failing to protect Americans against a contaminated supply of the blood thinner Heparin. At least 19 people died and hundreds became sick after consuming the contaminated product that had been imported from China. The Heparin case raised questions about the agency’s ability to regulate and inspect a growing flow of imported drugs and drug ingredients.

Compounding the problem of limited resources for plant inspections, FDA policies do not extend to the foreign study sites that produce more than 20% of clinical trial data submitted to the FDA.5 Moreover, at present, 80% of all active drug ingredients are imported.6 Finally, the FDA has reported an 800% increase in the number of cases of counterfeited pharmaceutical ingredients between 2000-2006.7 Exacerbating the already flawed foreign inspection process is the fact that the FDA does not bring its own translators or hire independent ones but rather relies on English-speaking representatives of the plants it visits to translate during the inspection process.

The Government Accountability Office stated that in order for the FDA to complete full inspections of foreign plants, it would require more than $56 million in additional funds with $15 million required to inspect Chinese plants every two years.8 The New York Times reported that at the current inspection pace, the FDA would need “at least 27 years to inspect every foreign medical device plant that exports to the United States, 13 years to check every foreign drug plant and 1,900 years to examine every foreign food plant.”8 Though the Bush Administration stated there were plans to improve the FDA’s ability to conduct foreign inspections, no funds were allocated for this purpose in President Bush’s yearly budget.

In order to apply for approval, drug companies must conduct clinical trials of products under development. However, the FDA does not require that these clinical trials be published and are therefore not subject to peer review. Mandated by the 1997 Food and Drug Administration Modernization Act (FDAMA), in 2000 the FDA created a national clinical trial registry for pharmaceutical corporations to submit clinical trial data. FDAMA required manufacturers to register their clinical trials at and to give a detailed account of both their experiments and eligibility requirements for research subjects. However, the FDA neither enforced compliance nor encouraged use of the clinical trial registry. While some manufacturers, such as Merck, did register their clinical trials, they only reported results that favored their products as they are not required to submit raw data. This led to suppression of full information about the efficacy and safety of new products under development.1

The FDA seems to be increasingly entangled with industry in ways that affect the process of review and regulation. For example, the Agency has frequently delayed the release of information about potential health effects of approved medical products. In the case of the Ortho Evra birth control patch manufactured by Johnson & Johnson that was linked to increased risk of blood clots and strokes and resulted in 50 deaths, the FDA did not make public these risks until six years after Johnson & Johnson’s own study showed such an association.9 After numerous lawsuits were filed against the manufacturer, Johnson & Johnson utilized the legal argument of pre-emption, claiming it could not be sued because the FDA had approved the patch and warning label. Testifying at a trial over the schizophrenia drug Zyprexa, former FDA scientist Dr. John Gueriguian who worked at the agency for two decades stated that the FDA did not always pursue strong warnings on products considered potentially dangerous, in part, because the pharmaceutical industry objects to warnings: “We at the FDA know what we can obtain and what we cannot obtain – and what we can’t obtain we will not ask.”9 By withholding negative findings, then using the FDA approval based on this limited information to preempt litigation from those harmed, the drug industry has made the FDA its ally in avoiding liability.

Under-funded, Understaffed and Overtaxed

Responsible for the safety of the nation’s food and drug supply, it might strike the American public as odd that the FDA budget is less than that of the school board of Montgomery County—the county in which the FDA is located.10 The FDA, particularly under the Bush Administration, has been chronically underfunded while at the same time it has been saddled with increasing responsibility.

The Prescription Drug User Fee Act (PDUFA) has been the source of both funding and controversy for the FDA. Adopted in 1992, the act requires pharmaceutical and biological products makers to pay fees for product applications and supplements. These fees are used to hire staff to assist in reviewing product applications, thus accelerating the process of drug approval. Though some have argued that user fees provide a vital source of revenue for an already underfunded agency and have suggested their application to overseas producers, a widely cited New England Journal of Medicine study suggested that PDUFA deadlines affect the safety of approved drugs with those approved right before a deadline being less safe than drugs approved at other times.11 By rushing through product applications, the FDA opens itself to the potential for an increase in recalls. PDUFA must be renewed every five years and over time has become more controversial. Public health critics of the PDUFA argue that it makes the FDA increasingly susceptible to industry pressure. Industry officials have critiqued user fees as unfair as the government is responsible for safety reviews.

Given these uncertainties about both the ability of the FDA to regulate the drug industry and the influence of Big Pharma on the agency through the use of such fees, the agency lost funding for a direct-to-consumer advertising fee provided by the FDA Amendments Act (FDAAA). Legislators also axed $1 million in funding for the new Reagan-Udall Foundation, a foundation created by Congress to work independently from the FDA to enhance product safety and innovation.

With a woefully inadequate budget and what many FDA staff characterize as a demoralizing work environment, the agency faces staff shortages that limit its ability to carry out inspection and regulation tasks properly. In 1997, Congress gave the FDA funding to support more than 9,000 scientists; today the number actually employed is less than 1,000.10 Further, the FDA is not able to match salaries in the private sector making it difficult for the agency to attract top candidates. Under the Bush Administration, the FDA has faced reduced funding and has lacked consistent leadership, often operating without a confirmed commissioner. Drug scandals and low morale have also lead to increased resignations, with many former employees citing pressure to express status quo scientific opinions and a belief that their work supported marketability more than health as reasons for leaving.12 A 2006 Union of Concerned Scientists survey of 5,918 FDA scientists found 1 in 5 reported that they experienced pressure from top-level FDA employees to gear their work according to political and corporate interests.13 Understaffing is also linked to slowdowns in drug approval rates with 19 new drugs being approved in 2007 compared to 53 approved in 1996.14

During this same period, Congress and the President gave the FDA more responsibility. For example, in the fall of 2007, Congress gave the agency increased power to regulate drug safety and data disclosure. However, the ability of the FDA to take on additional responsibilities is hindered not just from lack of adequate funding and high rates of turnover but also by an inefficient organizational climate. As a case in point, the FDA currently uses more than 300 non-compatible databases and has not created a centralized system which would allow researchers, medical professionals and the general public to access clinical trial information efficiently.1 The Office of the Inspector General (OIG) in the Department of Health and Human Services (HHS) has stated that the lack of an efficient FDA information system has hampered its ability to properly oversee research. Because of this, the FDA inspects less than 1% of clinical trials and less than 300 Institutional Review Boards (IRB) each year.14

Challenges from Across the Political Spectrum

The FDA has been a frequent target on Capitol Hill, in the press and from public health advocates. Democratic lawmakers have called for increases in user fees in order to improve surveillance and inspections. Earlier this year Representative Bart Stupak (D-MI), the chairman of the House Energy and Oversight and Investigations subcommittee, called for acting FDA commissioner Andrew von Eschenbach and other FDA officials to resign due to their “total lack of leadership.”14 Referring to scandals over Sanofi-Aventis’ antibiotic Ketek which caused liver damage and other serious side effects, Senator Charles Grassley (R-IA) stated, “There were sirens, red flags, and bullhorns, but it looks like the company and the FDA kept ear plugs and blinders on.”7

Public health advocates commonly critique FDA review and regulatory procedures as serving industry at the expense of public health. Consumers Union, Consumer Federation of America, US PIRG and others have repeatedly argued that the FDA has not adequately protected the American public from dangerous medical and food products and has charged the Bush Administration as crippling an already weak system. In a March 2005 joint letter to the committee charged with reviewing Dr. Lester Crawford to be the Commissioner of the FDA, the three agencies noted that the FDA suffers from a lack of adequate authority to regulate the pharmaceutical industry, from conflicts of interest which prohibited the public release of important research findings, and from the data reporting procedures which favor industry at the expense of peer review and open information.15 Similarly, in April 2008, the Prescription Project, Community Catalyst, National Physicians Alliance, Prescription Access Litigation, Community Catalyst and US PIRG gave comments urging the FDA not to adopt the draft guidance that would have allowed pharmaceutical representatives to distribute single studies to medical providers on the benefits of off-label drug use.16 The coalition called for hearings on what circumstances, if any, should allow for such practices but noted that as the draft guidance was currently constituted, it would benefit industry at the expense of good science and public health and safety. Also in April, Consumers Union Policy Counsel Ami Gadhi testified before the US House of Representatives Subcommittee on Health, Energy & Commerce Committee that “the call for a major overhaul of the FDA has now become a roar.”17

In March of 2005 the Center for Medical Consumers, Center for Science and the Public Interest, Command Trust Network, National Research Center for Women & Families, National Women’s Health Network and US PIRG launched a media campaign including a now defunct website, television and print ads detailing the flaws in the FDA regulation system. On one campaign flyer, the groups argued, “Unfortunately, the FDA is broken. The public’s health is being compromised to the point of negligence. The current Vioxx controversy is just the latest symptom of a system in crisis. It’s not all the agency’s fault. Congress has reduced the FDA’s authority, slashed enforcement budgets, and weakened its legal powers.” The groups then called for Congress to close loopholes and fix the FDA before further scandals occurred.

Conservatives arguing from a free-market perspective have suggested that the FDA cannot be reformed and should be abolished. Libertarian new source The Freeman, a publication of the Foundation for Economic Education, has argued that the FDA operates as a legally protected monopoly and that increasing the powers of and funding for the FDA will only exacerbate problems with the fledgling agency. In July of 2005 Freeman author Arthur E. Foulkes claimed that overcautious regulatory and review practices at the FDA kept important medications from market and from helping those who might be benefited by them: “How free is a land in which bureaucrats and politicians decide which health-care options are legal and which is not? No one is made better off by having peaceful options in life denied him. The FDA is beyond being reformed. It should be abolished.”18 In a later Freeman piece, author Larry van Heerden echoed the critiques of public health advocacy groups, noting the impact of user fees and corporate influence on the ability of the FDA to operate efficiently and objectively. However, rather than calling for increased reform and stricter standards to reduce corporate influence, van Heerden argued for abolishing the FDA in support of a free-market system and the responsibility of consumers to be self-informed: “In a system without such gate keeping, where drugs were available along with all the information on risks and benefits, the market would sort out the wheat from the chaff, dramatically lowering the financial stake in any single drug and reducing the tendency for drug companies to engage in fraud and deception.”19

Conservative critiques of the FDA are not new. In the early 1990s a coalition of conservative organizations raised concerns over the FDA regulatory process, particularly questioning agency restrictions on off-label use of medication and the slow rate of new drug approval. Industry leaders and conservative commentators continue to point to the slow down in approval rates as signs of ineffectiveness and an overly-cautious regulatory environment caused, in part, by a bevy of recent scandal over approved pharmaceuticals such as Vioxx. Though the FDA argues that new drugs will have to show marked safety or efficacy advantage over existing drugs in order to gain approval, industry officials claim that slowdowns increase development costs and inhibit competition by blocking new drugs from entering the market and taking market share away from established drugs. Despite overall arguments defending current approval procedures for new drugs, even the FDA’s own Science Board acknowledges that slowdowns in approval for new medical technologies and pharmaceuticals has a negative impact and “means that American lives are at risk.” 20

The FDA responds to its critics

The FDA has both defended itself against its critics and acknowledged deep structural issues that prohibit it from functioning properly. Facing increasing criticism, in 2005 the FDA asked the Institute of Medicine (IOM) to assess the safety of the U.S. drug system. The IOM released its report, “The Future of Drug Safety: Promoting and Protecting the Health of the Public” in September 2006 noting that the “perception of crisis” has compromised the credibility of the FDA and of the pharmaceutical industry;” that there is widespread agreement amongst stakeholders to improve the drug safety system; that the current system is currently hindered by “serious resource constraints that weaken the quality and quantity of the science that is brought to bear on drug safety” as well as a less than optimal organizational climate and insufficient and unclear regulatory authority; and a lack of transparency on the part of both the FDA and the drug industry to communicate safety concerns in a timely and appropriate manner.21 In response to the report, the FDA stated it would take steps to improve the integrity of the science behind the entire process of medical product safety; to improve risk communication policies and procedures; and to strengthen management and operations in order to ensure an effective U.S. drug safety system.22

The 2008 Presidential Election and the Chance for Reform

In their review of the history of the FDA, Borchers et al (2007) note that the “evolution of the FDA can be described as a series of ‘crisis-legislation-adaptation’ cycles: a public health crisis promoted the passage of congressional legislation, which was then followed by implementation of the law by the FDA.”23 Though this pattern reflects the history of the FDA at large, the authors note that current crises and challenges facing the FDA are so severe that only “strong and permanent leadership willing to redefine the role and procedures of the FDA” will be successful in getting the agency back on track. With the 2008 presidential campaign approaching and the state of the FDA in near permanent crisis, neither Democratic candidate Barack Obama nor Republican challenger John McCain have staked out strong positions on the FDA.

Senator Obama’s website offers some information about his stance on prescription drugs. His primary focus is on reducing the cost of prescription drugs by increasing the amount of safe pharmaceuticals imported from the developing world and increasing the amount of generic medications available on the market. While Obama notes the importance of breaking up insurance monopolies that drive up premiums, he does not call for similar moves in the pharmaceutical industry. Further, Obama takes no official stance on the FDA at large, plans to increase the safety of imported drugs or prescription drug marketing.

By comparison, in her campaign, former Democratic challenger Hillary Clinton, commented at more length on FDA issues. On the need for FDA reform, Clinton stated on her website: “Recently, concerns have been raised about the ability of the FDA to ensure the safety of drugs marketed to American consumers. I believe there is a clear need for post-marketing monitoring.”24 Like Obama, Clinton proposed to lower prescription drugs through the promotion of generic medicines and the importing of safe drugs from developing countries. To reduce prescription drug prices, Clinton argued for breaking up pharmaceutical monopolies to create generic competition. On the safety of drug imports, Clinton critiqued the Bush Administration for its failure to protect the American people from unsafe pharmaceutical imports:

If George Bush won’t start that process now, I will when I am President. As I laid out in my import safety agenda, I will require that foreign drug makers produce a certification that they have met American safety standards as a condition of import into the United States, confirmed by independent testing and inspection. I will open permanent FDA oversight offices in at-risk countries like China so that episodes like this one are not repeated. I will require foreign drug makers to accept random, surprise inspections, rather than notifying them in advance – and giving them a chance to clean up their act — as we do now. And I will stiffen civil and criminal penalties for violators. It is a basic obligation of government to protect its citizens. Americans can count on me as President to protect the food we eat, the toys our children play with and the drugs we take to make us healthy, not sick.25

Finally, Clinton noted that for every direct-to-consumer marketing dollar spent, pharmaceutical sales increased by $4.20. To address this issue, she suggested limiting such advertising, instituting a reporting requirement for financial arrangements between providers and industry, and protecting information about the prescribing practices of medical providers from being sold to drug manufacturers.

Senator McCain offers little information about his views on the FDA and the need for its reform on his presidential website. Like the Democratic challengers, McCain calls for increased imports of pharmaceuticals and faster genetic drug approvals. On McCain’s Senate website, transcripts of statements given to the Senate provide more information. In July 2002, McCain urged the Senate to pass the “Greater Access to Affordable Pharmaceuticals Act.” In his testimony, McCain argued against current pharmaceutical monopolies and for increased generic competition. In order to effect such a change, McCain argued: “This should not be done by imposing price controls or creating a universal, government-run health care system. Rather, a balance must be found that protects consumers with market-based, competitive solutions without allowing those protections to be manipulated at the consumers’ expense, particularly senior citizens and working families without health care insurance.”26 In support of the “Pharmaceutical Market Access and Drug Safety Act of 2004,” McCain specifically addressed the safety of drug imports noting, “To ensure the safety of this new system, the FDA would be required to regularly inspect Canadian exporters as well as domestic importers. The legislation also would require all importers and exporters to maintain a full chain of custody, or pedigree, for the drugs imported into the U.S.”27 Finally, in February 2005, McCain supported the “The Pharmacy Market Access and Drug Safety Act of 2005,” which would lower the cost of imported prescription drugs. He stated: “None of us have any illusions that enacting drug importation legislation will easy. Powerful special interests will continue to try to block us every step of the way. However, this is a battle worth fighting and winning for American consumers.”28

In a February 2008 blog entry from, Mark Senak of marketing and communications giant Fleishman-Hillard, briefly compared the positions of presidential candidates at that time on the FDA. He noted,

All of the candidates also tend to agree that they want to bring in new technology and devices to manage information, cultivate more prevention programs and to improve the quality of healthcare. But what was perhaps most surprising was the fact that as much as the candidates differ on the details of these reforms, they were nearly all in favor of two changes that would have a hefty impact on the pharmaceutical market place – Medicare Part D reform and the importation of prescription drugs. In other words, change with this election cycle is of course, inevitable, but it is also highly possible, if not probable, that candidates from both political parties will embrace these two reforms. To me, that was news. 29

Certainly it seems then that regardless of the winner of the next US presidential election, Americans can expect increased attention to the lowering the price of pharmaceutical products by increasing imports and access to generic medicines. However, neither Obama nor McCain have articulated their positions on the necessity for deep structural reform within the FDA and the need for creative solutions for both a source and level of funding that would allow the agency to properly review and inspect domestic and foreign food and drug applications, data and manufacturing plants.

In the coming months, health advocates may want to press the candidates to explain in more detail their positions on the FDA. More generally, the presidential candidates and those running for Congress will need to articulate how they propose to change the cozy relationship between the pharmaceutical industry and the FDA in order to allow the agency to fulfill its original mandate. Unless the next US President and Congress take a strong stand on the need for FDA reform and a transformation of the relationship between the FDA and the industries it regulates, it is likely that the trends of the past, crisis—legalization—adaptation, will continue at the expense of American health and public safety.


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3. Nissen, SE; Wolski, K. Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes. New England Journal of Medicine. 2007; 356(24):2457-2471.
4. Lipscombe, LL; Gomes, T; Lvesque, LE; Hux, JE, MSc; Juurlink, DN; Alter, DA. Thiazolidinediones and Cardiovascular Outcomes in Older Patients With Diabetes. JAMA. 2007;298(22):2634-2643. Wechsler, J. FDA Hit for Poor Clinical Oversight. Applied Clinical Trials. 2007;16(11):30-35.
5. Wechsler, J. FDA Hit for Poor Clinical Oversight. Applied Clinical Trials. 2007;16(11):30-35.
6. Washington Post. Fixing the FDA: Lack of funding inhibits crucial drug inspections abroad. Friday, March 7, 2008; A16.
7. Loewenberg, S. US FDA Feels the Heat from Congressional Hearings. The Lancet. 2008; 371:1565-1566.
8. Gardiner, H. U.S. Identifies Tainted Heparin in 11 Countries. New York Times. April 22, 2008.
9. Harris, G; Berenson, A. Drug Makers Near Old Goal: A Legal Shield. The New York Times. April 6, 2008.
10. Hubbard, W. The Overwhelmed FDA. The Boston Globe. June 3, 2007.
11. Carpenter, D; Zucker, EJ; Avorn, J. Drug-Review Deadlines and Safety Problems. New England Journal of Medicine. 2008;358(13):1354-1361.
12. Ross, W. What’s Up with the FDA? Medical Marketing & Media. 2008. Accessed at:
13. Union of Concerned Scientists. FDA Scientists Pressured to Exclude, Alter Findings; Scientists Fear Retaliation for Voicing Safety Concerns Public Health and Safety Will Suffer without Leadership from FDA and Congress. 2006. Accessed at:
14. Wechsler, J. Attacks on FDA Escalate. Pharmaceutical Technology. May 2, 2008. Accessed at:
15. Consumers Union; Consumer Federation of America; US Public Interest Group. March 15, 2005. Accessed at:
16. Prescription Project; Community Catalyst; National Physicians Alliance; Prescription Access Litigation; Community Catalyst; US PIRG. Comments Concerning the United States Food and Drug Administration Draft Guidance for Industry “Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices.” Docket No. FDA-2008.D.0053. April 21, 2008.
17. Consumers Union. Statement of Ami Gadhia Concerning Discussion Draft of “FDA Globalization Act” Subcommittee on Health, Energy & Commerce Committee U.S. House of Representatives. May 1, 2008. Accessed at:
18. Foulkes, AE. The FDA Cannot be Reformed. The Freeman. July 1, 2005.
19. van Heerden, L. Abolishing the FDA. The Freeman. March 1, 2007.
20. Harris, G. Advisers Say F.D.A.’s Flaws Put Lives at Risk. The New York Times. December 1, 2007.
21. Institute of Medicine. The Future of Drug Safety: Promoting and Protecting the Health of the Public. September 22, 2006. Accessed at:
22. Food and Drug Administration. The Future of Drug Safety: Promoting and Protecting the Health of the Public. FDA’s Response to the Institute of Medicine’s 2006 Report. Accessed at:
23. Borchers, AT; Hagie, F; Keen, CL; Gershwin, ME. The History and Contemporary Challenges of the US Food and Drug Administration. Clinical Therapeutics. 2007; 29(1):1-16.
24. Clinton, H. Accessed at:
25. Clinton, H. Clinton Responds to FDA Tripling Its Estimates For Heparin-Related Deaths. April 9, 2008. Accessed at:
26. McCain, J. McCain Urges Senate to Pass Generic Drug Bill Quickly. July 17, 2002 Accessed at:
27. McCain, J. Pharmaceutical Market Access and Drug Safety Act of 2004. April 21, 2004. Accessed at:
28. McCain, J. McCain Continues to Fight for Lower Prescription Drug Costs. February 9, 2005. Accessed at:
29. Senak, M. Where the Candidates Stand – A Side by Side Comparison and Conclusion. January 02, 2008. Accessed at:

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View CHW’s coverage on Corporations, Health and the 2008 Presidential Race:

Part 1: Following the Money
Part 2: Clinton, Obama and McCain on the Role of Corporations
Part 3: Clinton, McCain, Obama and the Food Industry