I recently stumbled upon a Federal Drug Administration report issued in response to President Obama's Regulatory Compliance Memo. The May 2011 report chronicles the agency's transparency efforts since 2009 as well as outlines goals for making additional data available.

A look into the FDA's website found mixed results as to the implementation of their stated goals at the time of this writing. The goals were to post the following on their website:

• Information about all the inspections the agency conducts related to market products, rather than the current disclosure of piecemeal information
• A significantly expanded set of enforcement letters
• FDA evaluations of importers
• Information about each case the Department of Justice files on FDA's behalf at the time the case is filed and when the case is resolved.

We were able to find the information specified in the first three goals - import filer evaluation outcomes, enforcement letters, an inspections database, a current list of press releases when DOJ cases are resolved, and a list of cargo thefts. However, we were unable to find any information regarding ongoing criminal investigations or recently filed cases.

The report details all the regulatory compliance data the FDA manages and breaks out which pieces are already publicly available. The list of publicly available data includes import refusal reports, recalls, annual enforcement statistics, and warning letters. The report also describes the agency's transparency efforts to date, which include forming an internal Transparency Task Force, posting a number of datasets on Data.gov, and launching a redesigned webpage and phone app.

A few days ago I received a plain white envelope in the mail from Abbott, the infant formula manufacturer. Inside was a form letter, telling me that the company was voluntarily recalling some of its cans of Similac powdered formula because they may contain beetle parts. The news was jarring; while I had just started my six-month-old son on solids, I wasn’t planning on including beetle bits on the menu.

The letter was dated September 27, five days after the company had announced the recall; while there were earlier news reports, somehow I’d missed them.

Coincidentally, I’d also just seen that that U.S. Food and Drug Administration (FDA), had launched a new data set on recalls, which we had called for earlier this year and which the agency later confirmed plans to do.  Sure enough, this new data set, which is available in programmer-friendly XML format, contains information about the Similac recall.

I also found the April report when McNeil Consumer Healthcare voluntarily recalled some batches of infant Tylenol and children’s Benadryl, among other drugs, which at the time  set me on a medicine cabinet emptying frenzy to find all the half empty bottles we used with my three kids.

The FDA’s release of these data in this format ultimately should be a boon to parents who would like to get this information in real time, once some enterprising programmers (hello Sunlight Labs!) start mashing it into some useful interfaces that makes it easier to search. It should also help public health, consumer advocates, journalists and others more easily analyze recall data to find out if there are patterns with particular companies or outbreaks. This can only help in a time that has seen recent massive recalls because of salmonella infestation in peanut butter and eggs.

But the FDA is the first to admit that the data are still lacking. The agency does not have the power to require companies doing recalls of drugs, medical devices, or food to provide a standard list of specific information. This includes such basics as an estimate of how many items are affected, the reason for the recall, and the geographic distribution of the product. (While some companies provide this information voluntarily, they’re not required to do so.) So last May, the agency issued a draft proposal--one of 21 transparency enhancing changes suggested by the agency--that it should seek such authority. Getting standardized information from companies would enhance the usefulness of this tool tremendously.

Last week the FDA also released another new data set, this one a database where the public can explore medical device inspections.However, the data only include 25 percent of inspections, and leaves out clinical trial inspections “because information about new medical device development is confidential.”

The trade journal Medical Device Daily (subscription required) calls the data “all bones and no meat,” because a user would still need to file a Freedom of Information Act (FOIA) request to get copies of actual inspection forms that give more detail.

For example, a search of St. Jude Medical, the company that we investigated in our award-winning “Heart of the Matter,” shows a list of five records; clicking on a record, however, shows us that the company was asked to take voluntary action to fix something, without saying why or what. These are data most useful to experts or investigative reporters with plenty of time and resources to dig in, not for ordinary consumers.

Incidentally, the new FDA recall databases appear to be available at Data.gov, the government’s data clearing house, but the medical device inspection data are not. All are now listed on the Sunlight Foundation’s National Data Catalog, here and here.

Next time there’s a recall of food or drugs affecting my kids I don’t want to wait to get an envelope in the mail. I want to get the scoop as soon as the government has it, with all the relevant details. I can’t act on what I don’t know.

This week's Food and Drug Administration (FDA) advisory committee's meeting on the controversial diabetes drug Avandia, which the New York Times reports on here, helps highlight the need for more transparency at the agency--but also show its limits. According to the Times, GlaxoSmithKline hid data from the Food and Drug Administration (FDA) revealing that the drug could cause health problems.

In May, FDA published this list of 21 draft proposals to increase transparency in the drug, medical device, and other aspects of the agency. Reading through the list is an exercise in: "what, you mean they don't already have to do that?"

For example, the  FDA would like to have the authority to ask companies to supply simple basic information about why a particular product has been recalled. (Remember salmonella in peanut butter?) This would ensure that the data it plans to release this fall (which we wrote about here) would be more complete.

The agency also proposes to give the public access to reports of "adverse events"--instances when drugs or medical devices are causing harm--in a format that is "searchable and and allows users to generate summary reports of this information."

The agency  says it would like to notify the public when a company files a request to investigate a new drug or medical device, thereby starting clinical trials, and also to inform us when and if that application is withdrawn, placed on hold, or terminated.

And it would like to issue "relevant summary safety and effectiveness information" for a product that has not gotten approval yet," if the Agency concludes that "disclosure is in the interest of public health." This speaks partially to the problem at the core of our investigation, "Heart of the Matter: How Congress and Special Interests Kept Clinical Trial Data Secret," which explored how Congress, under heavy lobbying by the drug and medical device industries, created a loophole that permits data to be withheld from the public for drugs and medical devices that don't make it to market.

However, in leaving it to the agency to decide, behind closed doors, when "disclosure is in the interest of public health," rather than letting all the information be free for reporters, experts, and everyone to see, this proposal is limited. As the journal Nature Medicine recently opined (subscription required):

In the end, new rules and regulations mean little if they are not implemented fully. The FDA, for instance, has yet to fully hew to its long-standing policy of releasing its analyses of drugs approved for new indications. Moreover, clinical trial sponsors are already required to register their trials with a US National Institutes of Health (NIH) database, but a recent analysis showed that only about half do so in a timely and complete way.

And, as the Times notes, current required posting of clinical trials "are often little more than cryptic references."

In the case of Avandia, where crucial data reportedly were withheld, the agency cannot make available what it doesn't have any more than the U.S. Federal Election Commission can provide information about campaign contributions that a candidate does not report.

Meanwhile, there's no guarantee that the FDA will implement all its transparency proposals. Comments are due on July 20 either at regulations.gov, or at www.fda.gov/transparency. So far there are not many comments posted. Afia Asamoah, the FDA's transparency initiative coordinator, says that often comments come flooding in the last few days before the the closing date.

Back in February, we were encouraging participation in the Open Government Directive conversations happening at federal agencies, since they were busy creating their open government plans, and in a uniquely responsive position.

Sunlight's Nancy Watzman, submitted a request for the Department of Health and Human Services, calling on them to release a database on drugs, medical devices, and food recalls by manufacturers. Nancy has been writing extensively on HHS and FDA data issues, including our award-winning investigation, Heart of the Matter.

HHS was indeed listening.

Nancy has more detail at the Reporting Group blog, but the short version is that HHS has decided to follow our suggestion, and release this database, which we expect to be released in the Fall. This is a victory for HHS, a victory for public awareness of medical information, and a victory for open government.

Some of the best storytelling elucidates how our system works, and compels us to do better. That's what is happening here -- a productive feedback loop, and one we're proud to be a part of.

Some open government/transparency posts from around the web:

The Food and Drug Administration, in conjunction with their Transparency Task Force, launched a transparency blog to discuss ways to make their operations more open to the public.

The White House is asking for more help on the Open Government Directive. They are looking for people to tell them the "three most important pieces of information you think every agency should be required to disclose about its operations." Also, they are seeking input on how the private sector could help the government mash up data.

Utah launched a new state government web site that looks very cool. Let us know in the comments what you think about this as a state government portal.

And in today's least surprising news, contracting in Iraq is plagued by a lack of oversight and corruption.

Following up on President Obama's January 21 memo requiring agencies to promote transparency and openness, the Food and Drug Administration (FDA) has created a Transparency Task Force to create recommendations to make the FDA more open and transparent. The largely secretive process of review and approval for drugs and medical devices is garnering the most attention as any attempt to open up this process would greatly affect thousands of corporations and the entire American public.

The FDA has had serious problems in disclosing problems with medications, over-the-counter drugs, and devices to the public with troublesome results. The New York Times writes, "the goal is to open up a system in which the agency failed to inform the public that a widely prescribed heartburn drug was especially toxic to babies; that a diabetes medicine and a painkiller increased heart attack risks; and that antidepressants increased suicidal thoughts and behavior in children and teenagers."

This transparency effort may be one of the more important ones for the administration, as most Americans rely on the FDA to provide accurate information as to whether a drug or device is not to be used, or what dangers may exist. An FDA that does not have the trust of consumers would assuredly cause increased risks in health decisions and lead to profit loses for companies manufacturing drugs and devices. Transparency is essential to instill trust in this area.

If the recommendations do include more transparency for drug and device reviews Congress would likely have to change laws that govern confidentiality at the agency. As the Times notes, passing a bill through Congress that the pharmaceutical industry has a great interest in derailing would be a difficult task.

The pharmeceutical industry spent a little more than $29 million on campaign contributions during the 2008 election cycle. The industry only spent more on campaign contributions in the 2002 cycle when Congress debated a bill to provide prescription drug coverage through Medicare. The industry spent a combined $234 million on lobbying in 2008 and has already spent $66 million this year. Any effort that is opposed by the pharmaceutical companies would have to overcome this juggernaut of political influence.

Transparency at the FDA is instrumental to a healthy and consumer confident country. The task force should ensure that the American consumer is readily and well information about the products they use.

This morning I visited the U.S. Food and Drug Administration’s (FDA) website to check, in the face of the current salmonella outbreak, if the Kroger “natural creamy” peanut butter that had been sitting in our cupboards was safe to feed my four-year-old son. I typed in the UPC code from the jar into the search bar on the page and discovered that it was not part of the recall. That was great—easy and quick. And Leo got his peanut butter and jelly sandwich.

Here at the Sunlight Foundation, we’re often critical of the government’s forays into internet communication. But this is an occasion for praise. In the weeks since the salmonella outbreak occurred, sickening at least 550 people in 43 states and contributing to eight deaths, the FDA has harnessed the internet and social media to get the word out to consumers.

The main agency web page about the outbreak summarizes the situation, gives helpful health information and provides links to congressional investigations and testimony. A “widget” that allows people to paste a recall search box on their web pages was used 1.4 million times in nine days, and the website itself was searched 20 million times. The FDA also made use of twitter (@FDArecalls), blogs, mobile alerts, and online videos to alert the public about the danger.

The FDA also offers a feed of the recall information in a variety of formats—the underlying raw, structured data on which products are affected by the outbreak—so that inventive programmers can mash it up with other information should inspiration strike. Over at the blog “Development in a Blink,” Doug Finke took the information and ran it through a social mapping program to come up with this visualization on the relationships among the companies and brands involved in the recall.

There's certainly more the agency could do. For example, it could create a way that people could text the name of a product to them from their cell phones and receive back a text saying whether the item is affected by the recall or not.

And there’s another long investigation to be told in how we’re in this salmonella mess in the first place. The food processing industry has long lobbied against giving the FDA stronger authority to regulate food safety, contributing $11.5 million in the 2008 federal elections alone and spending $29 million on lobbying last year. But with the salmonella crisis upon us, we commend the FDA for taking advantage of what the internet can offer in getting the word out.