The Ever-Changing World of the FDA

Photo Source: NCI, Linda Bartlett

Have you ever been watching T.V. when a commercial comes on? You see happy people playing with their kids, eating ice cream, or biking in the park while a soft spoken person tells you the benefits of their latest medication with soothing music playing in the background. Suddenly, the voice quickly starts listing possible side effects like nausea, heart attacks, stroke or even death. What is that all about? You have just been offered the message of regulatory science and the FDA.

Although safety is the utmost concern of regulatory science, enforcing magazine and T.V. ads is only a small part of it. Regulatory scientists examine toxicology reports, monitor clinical studies, make recommendations and restrictions, and may even perform laboratory tests when necessary to ensure marketed food and drugs are not hazardous to our health. They basically have the last say on whether these items are allowed on the market for consumption.

The Food and Drug Administration (FDA) is the key Federal agency for regulating food and pharmaceuticals for public use in the United States. This agency was established in the early 1900’s, but actually arose from the U.S. Department of Agriculture (USDA) Department of Chemistry created in the late 19th century to monitor the additives in food and drugs without regulatory powers.

In 1906, Upton Sinclair reported on the unsanitary conditions in meatpacking plants in his book, “The Jungle.” That year, public pressure led the federal government to pass both the Meat Inspection Act and Pure Food and Drug Act. The latter would eventually lead to the formal establishment of the FDA as a regulatory agency nearly two decades later.

Since then, the FDA has shown its flexibility through its numerous decisions. As times change, food and drug industries evolve and this means the FDA must always restructure itself to meet the needs of both companies and the public. In 1938, Congress gave the FDA authority over the expanding cosmetics and therapeutic device industries, which were then unregulated, after changes to the Food and Drug Act are proposed by the agency earlier that decade.  In the 1940’s, the FDA demonstrated its authority over medications, assuming responsibility for testing insulin used to treat diabetes and also requiring testing and certification of the popular antibiotic, penicillin.

Perhaps, the case most noted in FDA history is its decision on thalidomide in the 1960’s. Thalidomide was a sleeping medication that caused birth defects in many babies after its release in Europe. When the media reported the FDA’s role in preventing thalidomide’s release in the U.S., there was overwhelming public support for increased pharmaceutical regulation.

It has remained a regulatory force since then, although it has received a number of “facelifts,” especially in recent years. Many argue whether FDA regulations should be loosened to make new drugs available more quickly, but others feel they should remain very careful in their decisions to prevent unnecessary deaths. In fact, a 2010 Research!America poll indicates that Americans are split on this issue. It highlights why the FDA process has been a topic of debate for many years, factoring into the many changes made to the agency throughout its history.

How do you feel about the FDA and the role of regulatory science in the pharmaceutical industry?

Good luck Molly Round-Up

Hooray for Friday! It means the last day of in-office work for many of you, but also the weekly New Voices round-up. (You know that's what makes Fridays so exciting!)

Unfortunately, our Friday is bittersweet this week with the departure of our newest blogger, Molly Maguire. Molly finishes her internship today and is moving on to a position as an associate at Lewis-Burke Associates, LLC. We are sad to see her go, but excited for her new adventures and looking forward to hearing about her work there soon.

In that spirit of new adventures, two federal agencies have made major announcements this week:

The FDA releases the new sunscreen guidelines in time for another fun-in-the-sun summer. Looking for some good beach reading? Seems like neuroscience and brain books are the page-turners for 2011.

The USDA releases new food guidelines, explicitly encouraging Americans to eat more fruits, vegetables and whole grains. While raw fruits and veggies are predictable, it turns out figuring out what really has whole grains can be a bit trickier.

On this day in New Voices:
2010 - We launched our summer series, Images from Around the Lab. If you'd like to contribute pictures from your lab, drop us a line in the comments or via email at programs_at_researchamerica.org.
2009 - New Voices Matt, Takao and Rashada participated in the first blog point/counterpoint on policy related to Combating Cancer.

S&T Challenges in FY 2012: A View from the Helm

Last week, I attended the annual Science and Technology Policy forum convened by the American Association for the Advancement of Science. The conference was kicked off by John P. Holdren, the Science Advisor to the President and the Director of the White House Office of Science and Technology Policy (OSTP).

Dr. Holdren provided a glowing assessment of the President’s commitment to science, exclaiming that President Obama ‘gets it’ when it comes to the importance of science and technology. But with the recent debates over fiscal policy, the honeymoon is clearly over. We’ve already seen budget cuts to many of the research agencies and more may be on the horizon.

Dr. Holdren laid out what he believes to be some of the challenges facing federal R&D over the coming months. Basic research at the Department of Defense will likely come under increased scrutiny. The Department of Energy, which saw significant cuts during the recent budget deal, can expect attempts to downsize or eliminate programs like carbon capture and fusion.

At the National Science Foundation (NSF), the Directorate for Social, Behavioral, and Economic Sciences will likely be targeted. This particular Directorate was already singled out in Eric Cantor’s YouCut initiative. Historically, social sciences have always been a controversial component of the NSF portfolio and the current fiscal debate provides a new impetus for criticism.

Regulatory practices by the Food and Drug Administration will probably be challenged on the grounds that overly burdensome regulation slows job creation and dissuades companies from commercializing new products. Lastly, Dr. Holdren pointed out that programs supporting international collaboration will be squeezed, likely on the grounds that we shouldn’t be sending domestic dollars overseas.

Clearly, science is facing an uphill battle in an increasingly tumultuous political environment. If you care about the important research that our government supports, now is the time to speak out.

Urge Your Members of Congress to Participate in Your Congress-Your Health

Research!America and our partners have launched Your Congress-Your Health. Every Member of Congress has been invited to respond to a questionnaire about medical research, the deficit, and support for federal agencies that conduct research to improve health (NIH, FDA, CDC, NSF, and AHRQ). Please contact your Representative and Senators TODAY to urge them to respond to the questionnaire.

Cuts to research funding have already occurred at NIH, NSF, CDC, and AHRQ. That is why it is more important than ever for Americans know where lawmakers stand on these critical issues.

Take action now!

Food (and Drug Administration) for Thought

The Food and Drug Administration (FDA) goes through an enormous amount of work to ensure that our pharmaceuticals are safe and effective. It also, however, has to ensure that they’re real.

A recent 60 Minutes report examined the growing problem of counterfeit and poor-quality medicines. The story is yet another reminder that the FDA needs better financial support for its research and monitoring efforts, and that Congressional budget cuts to the agency could have a direct effect on you and your medicine cabinet.



For more on FDA’s regulatory work abroad, check out this Nature Medicine story, written by myself.

Do You Know Your Members of Congress?

Either way, today is the day to get in touch with your member in the House of Representatives.

The House is currently crafting a spending bill that may include unprecedented funding cuts to NIH, NSF, CDC, AHRQ and FDA. These cuts represent a major threat to the nation’s health, job growth and competitiveness.

It is critical that you contact your representatives TODAY so they know that cuts to American research are unacceptable.

It's about your job. Your health and the future well-being of your family. It takes 30 seconds to send a message and another 30 seconds to share with your contacts via email or Facebook.

Your minute could be the constituent voice that convinces Congress to protect research.

Come to the 2011 National Health Research Forum

The Research!America annual National Health Research Forum is an amazing opportunity to hear leaders of the health research community talk about the issues of today and tomorrow. Below is the full invitation and I definitely recommend anyone who can attending. (Bonus: you can meet some of your fellow New Voices in person!)

Tuesday, March 15, 2011
11:45 a.m. to 3:00 p.m.

Join Research!America for the 2011 National Health Research Forum on March 15! This annual event brings together heads of federal agencies for health and science research, as well as leaders from industry, academia and patient advocacy.

Lunch will be served at 11:45 a.m. and Research!America's chair, The Honorable John Edward Porter, will provide welcoming remarks beginning at 12:10 p.m. Michael Riley, managing editor of Bloomberg Government, and Clive Crook, senior editor of The Atlantic, will serve as moderators for two back-to-back panels with audience Q&A.

Confirmed panelists include:

• John J. Castellani, president and CEO, PhRMA
• The Hon. Mike Castle, member of U.S. Congress (1993-2011)
• Carolyn M. Clancy, MD, director, Agency for Healthcare Research and Quality
• Francis S. Collins, MD, PhD, director, National Institutes of Health
• Victor Dzau, MD, chancellor of health affairs, Duke University
• Thomas R. Frieden, MD, MPH, director, Centers for Disease Control and Prevention
• Margaret A. Hamburg, MD, commissioner, Food and Drug Administration
• Harry Johns, MBA, president & CEO, Alzheimer\'s Association
• David C. Page, MD, director, Whitehead Institute for Biomedical Research
• Ellen V. Sigal, PhD, founder and president, Friends of Cancer Research
• Elias Zerhouni, MD, president, global research and development, sanofi-aventis

Learn more about the National Health Research Forum, and register online today. Admission for Research!America members is complementary.

Research!America thanks our sponsors: sanofi-aventis; Pfizer, Inc; PhRMA; Howard Hughes Medical Institute; Battelle; Infocast; Zogby International; and Health Affairs.


For information other than sponsorship opportunities, contact Michelle Hernandez at mhernandez at researchamerica.org.

Make sure to leave us a comment and let us know you're coming!

Failures of U.S. Chemical Regulation

Image credit: Echoey13

In previous posts, I've shared how research demonstrates a link between endocrine disrupting chemicals (EDCs) and negative health effects, such as obesity. Since EDC exposures are a health concern, the government needs to identify chemicals of concern and implement policies to reduce exposures, as was done for lead. Unfortunately, U.S. chemical regulation is not a straightforward process.

Chemical regulation is split between several agencies. Two of the main agencies are the U.S. Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA). The FDA oversees chemicals we are exposed to through certain consumer products like pharmaceuticals, cosmetics, and food additives, while the EPA regulates exposures that are more environmental, such as air pollution.

Some authorities are further split, as is the case for water, with bottled water being regulated by the FDA and tap water by the EPA. As a result, individual contaminants could end having different maximum permissible amounts in bottled vs. tap water.

This fragmented regulation makes it difficult to protect public health. But there were also a large number of chemicals in commerce that were initially unregulated if they were not covered under other existing laws, such as the Federal Food, Drug, and Cosmetics Act which regulates pharmaceuticals. In an attempt to close this gap, Congress passed the Toxic Substances Control Act (TSCA) in 1976, which gave EPA the authority over all unregulated chemicals.

A major flaw is that TSCA treats new chemicals differently than chemicals that existed before the act. Existing chemicals were not evaluated and were just presumed safe. At the time TSCA passed, there were already about 62,000 chemicals in commerce. Regulation of new chemicals isn’t much better and has limited requirements. Companies are only required to submit available data and don’t have to test for toxicity. It is estimated that only 15% of new chemicals have complete health and safety data.

TSCA had the potential to unify regulatory authority, by giving the EPA authority over chemicals of unreasonable risk to health or the environment. For example, BPA is approved by the FDA as an indirect food additive, but because of concerns for human health, the EPA is using its authority under TSCA to investigate BPA.

However, the phrase “unreasonable risk” created another major hurdle, because it places the burden of proof on the EPA, and requires a significant level of evidence prior to regulatory action that can take years to develop. As a result, chemicals are only regulated when proven harmful rather than requiring they are proven safe to enter the market.

TSCA was introduced over 30 years ago. Today, there are over 80,000 chemicals approved for use in the products we use, such as household cleaners, shampoo, and makeup. But to date, the EPA has only been able to regulate 5 chemicals and require testing for about 200. I feel the numbers clearly show that TSCA has failed to protect Americans.

Image credit: Abeeeer

The U.S. Government Accountability Office (U.S. GAO), the agency that evaluates the effectiveness of government programs and policies, also believes TSCA has not given the EPA the necessary authority to protect human health and the environment. U.S. GAO put the EPA's process for "assessing and controlling toxic chemicals" on its "high-risk" list in 2009. The list includes federal programs, policies, and operations that should be a top priority for reform

Currently, Congress is considering legislation to reform TSCA. Senator Frank Lautenberg (D-NJ) introduced a bill called the Safe Chemicals Act of 2010 in the Senate. Representatives Bobby Rush (D-IL) and Henry Waxman (D-CA) have released a discussion draft of the Toxic Chemicals Safety Act of 2010 in the House. Only time will tell if these bills will provide Americans with meaningful reform that will improve public health.

This is Part 7 in the Chemical Exposures and Public Health series.
Part 1 - From Interest to Passion
Part 2 - An Environmental Health Risk
Part 3 - Lead: A Regulatory Success Story
Part 4 - Something My Body Needs Anyway?
Part 5 - Obesity's Elephant: Environmental Chemicals
Part 6 - Why Our Approach to Toxicology Must Change
Part 7 - Failures of U.S. Chemical Regulation
Part 8 - Cleaning Up Our Act
Part 9 - Environmental Health Research Saves Lives and Money
Part 10 - Call to Action

Acronyms, Abbreviations and Agencies

Washington, DC is a city whose vernacular is deeply rooted in acronyms and abbreviations. Sometimes it feels like you need a top secret clearance or access to a guide book of all the different non-profits, for-profits, voluntary health groups, patient groups, and federal agencies. For (completely made up) example, "We recently saw the CBO's numbers for LHHS, but they don't match the OMB numbers that we saw a month ago regarding NIH or CDC."

If you understood that, hooray for you! If not, you're not alone. Heck, I'm pretty sure the CBO doesn't even have numbers for LHHS. But the point is there are an awful lot of groups around here talking about an amazing number of things - many of which deserve our attention.

Here at New Voices, there are four federal agencies we talk about a lot:

1. AHRQ - Agency for Healthcare Research and Quality
2. CDC - Centers for Disease Control and Prevention
3. FDA - Food and Drug Administration
4. NIH - National Institutes of Health

We're going to help decode these four multi-letter names so you can see the agencies behind them over the next few weeks. Come back tomorrow for Kimberly's look into the CDC.