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A Salmon on Every Plate

Monday, October 17th, 2011

 

President Herbert Hoover supposedly promised Americans “a chicken in every pot” during his 1928 campaign. Chicken was an expensive delicacy then, so his message was about raising living standards, not ending hunger. Today, chicken is a low-cost source of protein and a mainstay of the American diet.

 

FDA Matters hopes that salmon (and other fish) will also become sources of low-cost protein over the next two decades. FDA is nearing the end of a long regulatory process, the outcome of which could be approval of a faster growing genetically-engineered Atlantic salmon. FDA must overcome opposition from environmental groups…and politicians and companies trying to protect the market for Pacific salmon.

 

The health benefits of fish are well-known. They are also a valuable source of dietary protein. However, our oceans are over-fished and aquaculture is now the source of almost 50% of the fish consumed worldwide. Expanding the availability of fish products meets a growing demand and is an important component of improved nutrition for Americans.

 

The proposal before FDA is for a genetically-engineered (GE) salmon that is biologically and chemically identical to the Atlantic salmon that is served in restaurants and at our own tables. The only difference is the inclusion of a Chinook salmon gene that provides the potential to grow Atlantic salmon to market size in about half the time.

 

Opponents have labeled the product as “Franken-fish.” It’s a catchy slogan that tries to vilify over a decade of scientific research and discredit several years of FDA review. Ultimately, the appeal is to emotion—that something dramatically new and different must automatically be dangerous. Decisions about new and different products are hard for FDA, as I wrote a few week weeks ago in a column entitled: “FDA and Things that Might Go Bump in the Night.”  

 

Approval of genetically-engineered animals will always require serious consideration of safety, environmental and ethical issues.  In this case—FDA’s first application for approval of a GE food product–the agency has been fortunate to have what might be considered a favorable factual context. No one questions the legitimate demands for more plentiful, high quality supplies of salmon. Further, the sponsor has agreed upon multiple redundant safeguards. For example, the GE salmon will be only sterile females and will be grown in inland fisheries with no access to either wild or farmed salmon stocks.

 

FDA has done its homework—digging deep into the relevant science and taking the time to consider all aspects of the issue. An agency decision is considered imminent and likely to be favorable….unless Congress tells it otherwise. A showdown may occur this week when the Senate considers the FY 12 appropriations bill for the Agriculture Department and FDA.

 

The House version already contains restrictive language forbidding the agency from spending any of its FY 12 monies to approve the application. However, according to some reports, only about a dozen Representatives were present when the amendment was adopted by voice vote during floor consideration.

 

In contrast, when the issue comes before the Senate this week, there will be debate and almost certainly a vote. Currently, about a dozen Senators are known to support the ban, with most of them from Alaska, California, Oregon and Washington, states that are the primary sources of Pacific salmon sold in the United States. 

 

Healthy, affordable high-protein food is always a desirable dietary option. At some time in the future, salmon could be as affordable as chicken if we allow the development of salmon that can be grown faster.  

 

The current fight is not just about “a salmon on every plate.” It is also about whether Congress will substitute its political judgments for FDA’s scientific decisionmaking. FDA Matters hopes that enough Senators will vote for FDA and against regional economic interests that want to protect existing sources of salmon production.

 

Steven

More information about salmon, aquaculture regulation of genetically-engineered foods and the current controversy can be found at: http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/VeterinaryMedicineAdvisoryCommittee/ucm222635.htm and http://www.aquabounty.com/PressRoom/#l7

FDA and Things that Might Go Bump in the Night      September 18th, 2011

FDA’s everyday business requires balancing risk and benefit as these might apply to a particular medical product or a new food. Occasionally, FDA is faced with a much larger responsibility: judging a breakthrough technology that could bring great benefit or great sorrow to humankind. Who can confidently know in advance which it will be?

Still, FDA must decide. If they say “yes,” whole new industries and benefit may be created for patients and consumers. Or, the world and humankind may be subject to devastation. Today, the agency is faced with just such challenges in dealing with nanotechnology, genetically-engineered (GE) animals, and synthetic biology. Read the rest of this entry

Posted in FDA and Congress, FDA and Industry, FDA Appropriations, Food Issues | No Comments »

FDA and Things that Might Go Bump in the Night

Sunday, September 18th, 2011

 

FDA’s everyday business requires balancing risk and benefit as these might apply to a particular medical product or a new food.  Occasionally, FDA is faced with a much larger responsibility: judging a breakthrough technology that could bring great benefit or great sorrow to humankind. Who can confidently know in advance which it will be?

 

Still, FDA must decide.  If they say “yes,” whole new industries and benefit may be created for patients and consumers. Or, the world and humankind may be subject to devastation. Today, the agency is faced with just such challenges in dealing with nanotechnology, genetically-engineered (GE) animals, and synthetic biology.   

 

Thirty years ago, FDA gave a cautious “yes” to the first biotechnology studies that eventually became important medical products to treat cancer, arthritis, MS and many other diseases. The world is a better place as a result.

 

In retrospect, the decision was right, but at the time, it wasn’t clear. Scary visions of mad scientists and technology run amok were powerful forces in the early days of biotechnology. In response, FDA took great care in setting up an appropriate regulatory environment.[1]

 

Not surprisingly then, FDA proceeds carefully when new areas of science and technology have great potential, but could also be the source of great harm.  

 

One such area is nanotechnology, “the science involving manipulation of materials on an atomic or molecular scale.” The agency is concerned because: “materials at the nanoscale can have different chemical, physical, or biological properties compared to their conventionally-scaled counterparts.” What we consider safe may not be safe if made from nano-particles.[2]

 

FDA responded in 2006 by forming a Nanotechnology Task Force, which still exists. It released an assessment and recommendations in 2007 that have guided FDA’s subsequent actions. These include the first draft guidance on nanotechnology in regulated products, published earlier this year. More extensive guidance is expected in the future.[3]

 

Yet another science with great potential for benefit, but also possible risks, is genetically-engineered (GE) animals. FDA has been monitoring this field for two decades and accelerated its efforts over the last 5 years as GE animal products have gotten closer to filing for approval.[4]

 

Currently, the agency is working (slowly and carefully) on GE Atlantic salmon that have been modified to grow faster.[5] If approved, it would also be the first GE animal to become part of our food supply. Opponents call it “Franken-fish” and allege that it will be dangerous to humans and the environment.

 

The agency has held hearings, sought feedback from advisory committees and tried to solicit all viewpoints. When it finally decides, it wants to be certain that the result will be beneficial and not harmful to our society.

 

While nanotechnology and GE salmon are well-along in the decisionmaking process, the FDA is only just beginning a similar cycle regarding “synthetic biology.” While “synthetic biology” can be defined a number of ways, it is generally considered to be “the use of molecular biological techniques and chemical synthesis to mimic and even redesign natural biological systems.”[6]

 

Synthetic biology raises the specter of artificial life (more mad scientists running amok?). The Presidential Commission for the Study of Bioethical Issues released a report in December 2010[7] and NIH is also deeply involved. FDA is watching, adding staff with appropriate backgrounds and planning carefully, knowing that product-specific questions about synthetic biology are coming its way.

 

As with biotechnology thirty years ago, FDA continues to make tough decisions about dramatic new technologies that can alter our way of life—for good or bad. Some fear will always be with us, if only because a wrong decision might be catastrophic. Past experience shows us the agency will be appropriately deliberative before coming to a conclusion.

 

Steven

 [1] http://www.fda.gov/AboutFDA/WhatWeDo/History/ProductRegulation/SelectionsFromFDLIUpdateSeriesonFDAHistory/ucm081964.htm

 [2] “There is a virtual consensus among scientists that the toxicology of engineered nanomaterials is largely unknown, and that toxicity data cannot be extrapolated from existing toxicology studies conducted on larger-scale materials.” http://www.fda.gov/ScienceResearch/SpecialTopics/Nanotechnology/NanotechnologyTaskForce/ucm118910.htm

 

[6] Testimony of Dr. Anthony Fauci on synthetic biology: http://www.hhs.gov/asl/testify/2010/05/t20100527a.html

Posted in Drug Approval and Access, FDA and Industry, FDA Leadership, Food Issues | 3 Comments »

FDA’s Busy Summer of 2011

Tuesday, September 6th, 2011

Once upon a time, Washington slowed a little over the summer. Those days are long gone…and this was a particularly busy summer. Congress went down to the deadline on the debt limit/deficit reduction legislation, then left town for August. There was a continuous stream of FDA headlines in June, July and August.

FDA Matters focused on a number of the most pressing issues: post-market safety and surveillance; barriers and opportunities for increased drug discovery and approvals; the rising tide of imports; prospects for biosimilars and medical devices; FDA funding; and various crises facing the agency.

Here is a recap of the summer’s stories:

FAQ: How Biosimilars Will Transform the Marketplace      August 21st, 2011

Biosimilars will be a huge success–used by most prescribers at least some of the time. Much of the current negativity about the market for biosimilars is fed by a mismatch of expectations: the Biologics Price Competition and Innovation Act (BPCIA) is barely 18 months old, while the transformation of the marketplace will take a decade or longer. FDA Matters explores the likely evolution of the marketplace in a set of FAQs.  Read the rest of this entry

FDA Funding Prospects Altered by the Budget Control Act     August 14th, 2011

The Budget Control Act of 2011 (BCA) will have a heavy impact on FDA’s future. Under this new law, most discretionary spending programs will shrink—not merely cease to grow. Yet, FDA’s growing responsibilities and resource needs are not diminished because federal spending is being reduced. Our nation is less safe and less healthy if FDA cannot excel at its mission. Read the rest of this entry

People, Not Science, Make Decisions  August 8th, 2011

To FDA Matters, the people making the decisions at FDA are its strength. They are smart, conscientious and committed. Yet, when asked about bottlenecks at FDA, I have to admit that people slow the process down. There are good reasons why this is so. Read the rest of this entry

Medical Device Melodrama: A Great Story With a New Plot Twist  August 1st, 2011

Two years ago, FDA Matters urged FDA and Congress to review the 510(k) approval process for moderate-risk medical devices and predicted meaningful changes that would work for FDA, industry and consumers. FDA and industry have been proceeding along these lines (albeit with some tough negotiating and lots of rhetoric)…until the Institute of Medicine (IOM) declared that the current system is so flawed that a new regulatory framework is needed.  Read the rest of this entry

FDA, Reorganization and the Four Crises    July 24th, 2011

Dr. Hamburg’s reorganization plan addresses four crises that beset the agency: industry discontent with the medical product review process; public concern about import safety; implementation of the Food Safety Modernization Act; and Congressional concerns that the agency is inefficient in its use of resources. The new structure should drive better decisonmaking and greater productivity…. at a time when the agency is struggling to fulfill its growing mission and faces the potential for budget cuts.  Read the rest of this entry

Complexity, Uncertainty, Unpredictability: Not Necessarily Bars to FDA Approvals      July 17th, 2011

In most discussions of science and medicine, there is an implicit assumption that the human body is a complex biological machine. “The human body as a machine” is a metaphor, not a fact. Once we accept this, FDA Matters believes we can become liberated from unrealistic expectations about medical discovery and FDA’s role as a gatekeeper for new products that benefit patients. Read the rest of this entry

Should FDA Have an Independence Day?     July 4th, 2011

FDA Matters thinks that making FDA an independent agency will not make FDA more effective or more efficient. Although the idea is not truly harmful, proposing independent agency status is a seductive distraction from the tough job of improving FDA. Read the rest of this entry

Imports: FDA Issues a Cry for Help   June 26th, 2011

 No challenge to FDA’s mission looms larger than the rapid globalization of the world markets for food, drugs, medical devices and other FDA-regulated products. By way of making this point, the FDA released a special report, entitled “Pathway to Global Product Safety and Quality.”  FDA Matters read the report carefully and heard a cry for help, if not an actual primal scream. Read the rest of this entry

Post-Market Safety: Getting the Most Out of Inferences That Aren’t Proofs   June 21st, 2011

FDA has expanded its post-market efforts, including development of a monitoring system (called Sentinel) that will be able to track drug usage and medical history information on tens of millions of patients. Although such information will be useful, it can only provide post-hoc inferences, not proof of causation. Even with this limitation, FDA Matters thinks developing the system is worthwhile and may provide multiple benefits.  Read the rest of this entry

Steven

 

 

Posted in Drug Approval and Access, FDA and Congress, FDA and Industry, FDA Appropriations, FDA Leadership, Follow-on Biologics, Food Issues | No Comments »

Imports: FDA Issues a Cry for Help

Sunday, June 26th, 2011

No challenge to FDA’s mission looms larger than the rapid globalization of the world markets for food, drugs, medical devices and other FDA-regulated products.  By way of making this point, on June 20, the FDA released a special report, entitled “Pathway to Global Product Safety and Quality.”  

FDA Matters read the report carefully and heard a cry for help, if not an actual primal scream.

The report provides startling statistics on the recent and future growth of imports. A decade ago, 6 million shipments of FDA-regulated goods passed through our nation’s 300 ports; this year the number will quadruple to 24 million shipments.

The impact is across all areas of FDA responsibility. Currently, 60% of fruits and vegetables and 80% of seafood consumed in the US are imported. About 80% of active ingredients found in pharmaceutical products (not finished products) originated abroad. More than 35% of the US medical equipment market is imported devices.

The world is an unsafe place. Despite that, Americans are not going to restrict themselves to seasonal and locally grown food. Nor will we limit ourselves to the drugs and devices that can be developed and manufactured using only ingredients and parts that come from within the US.

We count on FDA to be sure our foods are safe and medical products safe and effective, regardless of origin.  However, imports inspire less confidence because there are hundreds of thousands of products made under local laws and business practices. We have much to be concerned as these numbers continue to grow.  

Even with additional resources, new legal authorities, international cooperation, improved strategies, complex databases and a bunch of good luck…keeping the American people safe will require the agency to invest several times more effort than it has in the recent past.

FDA’s plan is logical and appropriate:

1) FDA, in close partnership with its foreign counterparts, will assemble global coalitions of regulators dedicated to building and strengthening the product safety net around the world.

2) With these coalitions, FDA intends to develop a global data information system and network in which regulators worldwide can regularly and proactively share real-time information and resources across markets.

3) FDA will continue to expand its capabilities in intelligence gathering and use, with an increased focus on risk analytics and thoroughly modernized IT capabilities.

4) FDA will effectively allocate agency resources based on risk, leveraging the combined efforts of government, industry, and public- and private-sector third parties.

In short, FDA’s strategy is: let’s build the food, drug, and device equivalent of Interpol, then “let’s get the bad guys before they get us.”

This seems like a good approach, but it is not enough. In a speech in April, Dr. Murray Lumpkin, Deputy Commissioner for International Programs, referred to FDA-regulated products as coming from “roughly 200 countries, using 825,000 importers through over 300 US ports-of-entry.” How do you possibly manage that?   

I can’t claim to know the answer. Significantly increased funding for import safety is essential. A larger FDA overseas force is necessary to work with other governments and set up international standards. Tougher US laws are needed. We have learned, however, that it is hard to prevent problems when one or two business owners are prepared to willfully neglect standards and heedlessly adulterate food and drug products.

Our only choice is to respect what FDA has accomplished…..and give them the support and funding (and maybe some out-of-the-box ideas) to do an even better job.

Steven

FDA’s Report on Imports: http://www.fda.gov/AboutFDA/CentersOffices/OC/GlobalProductPathway/default.htm

Dr. Lumpkin’s presentation:  Viewing the world through the FDA international lens: Advancing domestic public health through international engagement. Slides from presentation given to membership of the Alliance for a Stronger FDA, April 26, 2011.

 

Posted in FDA and Congress, FDA and Industry, Food Issues, Planning for FDA's Future, Uncategorized | No Comments »

Forget the Hype: Change Takes Time

Monday, March 21st, 2011

FDA Matters is always impressed by how much FDA does. The everyday tasks are overwhelming: reviewing, approving, monitoring and inspecting the products and facilities responsible for 80% of our food supply and 100% of drugs, biologics, medical devices, vaccines, and animal drugs. Then there are the policy issues, big and small, that must be tended to.

These are largely functional tasks—someone has a job (or several) and does them. Yet, FDA has another life, as the bridge to the future of foods, drugs and devices. This responsibility is vitally important to our nation. It also takes time to bear fruit. (more…)

Posted in FDA and Industry, FDA Leadership, Follow-on Biologics, Food Issues, Planning for FDA's Future | No Comments »

Two Strategies for FDA Legislation in 2011

Tuesday, December 7th, 2010

The current Congress will be remembered for its 15-month battle to enact health reform legislation. The FDA-related accomplishments have been less visible: an abbreviated approval pathway for bio-similar drugs included in the health reform law; and a food safety bill that may be enacted before Congress adjourns later this month.

In both cases, unanimity was never possible, but working majorities formed and prevailed. FDA Matters believes that any FDA-related legislation will falter in 2011 if it does not follow the strategy behind one or the other of these efforts.  (more…)

Posted in FDA and Congress, FDA and Industry, Follow-on Biologics, Food Issues, Uncategorized | 1 Comment »

FDA’s “Summer of Safety Concerns”

Sunday, September 5th, 2010

One of industry’s great fears is that FDA will become obsessed by theoretical or miniscule safety concerns and ignore the difficult realities of providing consumers with a varied and plentiful food supply and providing patients with effective medical therapies.

It is even possible to think this has occurred. It has been a long summer of media and Congressional attention to safety: whether drug manufacturing, medical products already on the market or Salmonella contaminated eggs. A closer look suggests to FDA Matters that theoretical safety risks and inappropriate FDA concerns about safety are not the issue. (more…)

Posted in Drug Approval and Access, FDA and Industry, Food Issues | No Comments »

Hot Town, Summer in the City—2010

Sunday, July 11th, 2010

For the news media, the only FDA story this coming week will be the two-day advisory committee meeting reviewing the diabetes drug, Avandia. Based on an earlier article (link below), FDA Matters will be looking at how Dr. Hamburg’s FDA handles the discordant voices coming from within the agency.

Missing from public dialogue is the extraordinary (perhaps unprecedented) number of large, consequential projects that FDA will be working on this summer. Every part of FDA is involved in some initiative that could become a “game-changer” for the agency. (more…)

Posted in Drug Approval and Access, FDA Accountability and Transparency, FDA and Congress, FDA and Industry, FDA Leadership, FDA-NIH Relations, Follow-on Biologics, Food Issues, Orphan Drugs | No Comments »

“Safe”: Many Meanings Complicate FDA Policymaking

Sunday, May 23rd, 2010

FDA Matters is in favor of safe foods and safe medical products. Who isn’t? If you are a consumer, maybe that’s all that matters.

However, being in favor of safe foods and safe medical products is not enough if you are FDA, the media, Congressional authorizers and appropriators, OMB, and industry. It sounds good, but what does it really mean? In the FDA context, “safe” means many things, some of which are barely related to each other. (more…)

Posted in FDA and Industry, FDA Leadership, Food Issues, Planning for FDA's Future | 2 Comments »

FDA’s Growing Presence Outside of the Washington Beltway

Thursday, February 11th, 2010

The federal government is closed for the fourth straight day. However, it would be more accurate to say: closed in the DC area. A significant part of FDA is open and has been all week….making this a good time for FDA Matters to acknowledge and explore the growth of FDA in places far from the Washington Beltway. (more…)

Posted in FDA Leadership, Food Issues, Planning for FDA's Future | No Comments »

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