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FDA’s “Summer of Safety Concerns”

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.

As laid out in more detail in “Safe”: Many Meanings Complicate FDA Policymaking, there is a strong tendency to think of FDA’s safety mission as if it were one type of activity. There are at least six different meanings of “safe” that are relevant to FDA.

For example, we want our food to be “inherently safe,” “safe from intentional and negligent contamination” and “safe from unintentional contamination.” Much of FDA’s attention to food safety this summer has been about unintentional contamination (seafood in the Gulf and eggs with Salmonella).

The agency needs more resources for food inspections and, in the case of eggs, it should benefit from implementation of new standards that were already being phased in. New food safety legislation should also help, but only if Congress appropriates the funds for it to work properly. Whatever substantive or political barriers exist to passage of this legislation, there does not appear to be widespread disagreement about FDA’s role or the standards it applies in assuring food safety.

We want medical products (drugs, biologics and devices) to be “safe as tested pre-approval,””safe as used post-approval” and “safe as manufactured and distributed.” None of this summer’s medical product safety issues appear to be about nuances of safety or shifts in FDA’s approach to balancing risk and benefits in these three areas of safety concern.

Concern over potential cardiovascular risks from the diabetes drug Avandia existed before its approval. I do not see this as an issue of FDA standards or focus—but rather conflict over the proper interpretation of studies and data. Policymakers and industry should be wary of drawing any larger meaning from this about FDA’s policies on safety.

Much of the rest of the summer’s medical product safety issues were about “safe as manufactured and distributed.” There seems to be consensus—even among those with problems– that real lapses occurred and were violations of reasonable safety policies. As described in prior columns, this requires CEO’s to take manufacturing and distribution seriously, rather than for FDA to re-think its existing safety policies.

While this may have been FDA’s “summer of safety concerns,” there doesn’t seem to have been any change in how the agency balances competing demands involving safety. As the FY 11 appropriations process comes to a conclusion this Fall, there is good reason to put more funding into safety analysis and enforcement. Drawing any larger conclusions is, at best, premature and probably unwarranted.


Since before Memorial Day, FDA Matters has blogged extensively about FDA and safety issues, although this was not planned. Here is a sampling of columns:

“Safe”: Many Meanings Complicate FDA Policymaking 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.
Read the rest of this entry »

Not Too Soon to Consider the Hamburg Legacy May 27th, 2010

May 18 marked one year since Dr. Margaret Hamburg was sworn in as Commissioner of the US Food and Drug Administration. The challenges are great, the torrent of issues is never-ending and most days you can smile but you can’t win. Nonetheless, I think it has been a very good first year for her and for Principal Deputy Commissioner, Dr. Joshua Sharfstein. It may seem premature to be discussing “the Hamburg legacy.” But you know that she is thinking about it (all commissioners do), so why can’t FDA Matters talk about it? Read the rest of this entry »

Quality Control Woes: What’s a CEO to Do? June 2nd, 2010

Medical products companies are struggling to assure FDA and the American people that their products are “safe as manufactured and distributed.” We don’t know whether quality control has become lax, FDA is discovering more problems or industry has just had a run of bad luck.

We do know that quality control relies on a lot of people maintaining tough standards…and that manufacturing is rarely a priority of a drug and device company CEO. Earlier this year, in the wake of Toyota’s problems, FDA Matters asked: “what’s a CEO to do?” Read the rest of this entry »

FDA to Industry: Contractors R U June 17th, 2010

It seems a rather uncontroversial proposition: FDA-regulated companies are responsible for their vendors, including every contracted piece of work that is done on the company’s behalf. If problems develop, it makes no difference whether a company did it…or a contractor did it for them. Two seemingly unrelated items this week suggest that FDA is becoming concerned about whether FDA-regulated companies are overseeing their vendors. Read the rest of this entry »

Hot Town, Summer in the City—2010 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. 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. Read the rest of this entry »

Benefit, Risk and the Coming Age of REMS August 8th, 2010

FDA supposedly swings back and forth between emphasizing “expedited approvals of promising therapies” and “extended pre-approval examination of every safety issue.” Current thinking is that FDA is now leaning more toward the safety end of this spectrum.

FDA Matters thinks a lot of this is perceptual. Approval decisions reflect FDA’s honest and relatively clear judgment on medical need, quality of the clinical data, and the risks and benefits of a specific product. Mostly, I can understand FDA’s decisions, even when I don’t agree. Still, there is a lot of tension within FDA and with various stakeholders about approvals versus safety risk. Read the rest of this entry »

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