By Leah Voigt*
March 5, 2010
Industry Seeks FDA's Regulatory Guidance on Discussing Products in Social Media
Companies making products regulated by the U.S. Food and Drug Administration (FDA) have limited their participation in social media forums because FDA has not yet made clear what types of communications are acceptable, several drug companies told FDA recently. In comments on how FDA should handle companies' social media participation, AstraZeneca, for example, pointed out it has a presence on Facebook, Twitter, and YouTube, but "these uses are intentionally quite limited and often involve providing corporate, non-product information."
"Without guidance, our activities are limited in a manner that we believe is not in the best interests of informed health care decision making," AstraZeneca wrote in comments dated February 26, 2010. "In our absence, consumers will turn to information sources that are not regulated and not always well informed." FDA accepted comments regarding the use of social media in the promotion of regulated products through February 28, 2010, and the agency now is expected to prepare guidance on the issue.
In the spring of 2009, FDA asked fourteen drug companies--including Pfizer, Eli Lilly, and GlaxoSmithKline--to stop using sponsored links on Internet search engines to promote their drugs because the links failed to communicate risk information. FDA notified the companies through what are known as "untitled" letters. In February 26, 2010, comments to FDA, the Interactive Advertising Bureau, based in New York, brought up those letters in the context of the current social media discussion. "Since the issuance of these letters, there has been some degree of uncertainty regarding the requirements for advertising pharmaceuticals online. Many pharmaceutical companies have not fully embraced online advertising, with the unfortunate consequence that consumers have less access to information about prescription drugs that may benefit them."
Just as FDA has made clear what is acceptable for product promotion in traditional media, such as television and radio, the agency should "bring the same level of certainty to the online arena," the advertising bureau said. The pharmaceutical industry's use of social media raises regulatory issues that companies must be aware of, attorneys said at a recent American Bar Association meeting in Phoenix.
FDA for several months has been discussing companies' social media responsibilities in promoting their products. FDA is expected to consider comments it received as it prepares guidance on the topic.
Jessica Coomes, Industry Seeks FDA's Regulatory Guidance on Discussing Products in Social Media, BNA's Health Care Daily Report (Mar. 3, 2010) (note: registration is required to view this content).
Infection Rates Drop as Michigan Hospitals Turn to Checklists
From the surgical suite to the intensive care unit (ICU), checklists are protecting patients from harm, a study says. But some advocates say that they are not a cure-all. For years, catheter-related bloodstream infections seemed to be a sometimes unavoidable complication of caring for the sickest patients in intensive care units. The infections kill 17,000 patients annually, and the average cost of caring for an infected patient is $45,000, studies show.
But then a stunning thing happened--a group of Michigan hospitals implemented a relatively simple set of interventions, including a checklist of infection-control practices, and their average infection rate dropped 66% in one year. The median central-line infection rate fell to zero per 1,000 catheter days, compared with a national average of 5.2. The achievement was because of hand washing, using full-barrier precautions when inserting central venous catheters, cleaning the skin with chlorhexidine, avoiding the femoral site for insertion, and removing unnecessary catheters.
Three years after the project began, eighty-five Michigan ICUs have improved their success. The average infection rate has dropped 86%, while the median rate remains at zero, according to a February 4, 2010, study published in the British Medical Journal. "Most of the time these things go a different way," said Peter J. Pronovost, MD, PhD, lead author of the study and a consultant on the Michigan project. "The history is that quality improvement is like an accordion. You push on it, it goes in, and then you stop pushing on it and it comes back out."
Atul Gawande, MD, MPH, hailed the Michigan project's continued effectiveness. "It's remarkable," said Gawande, who has promoted the checklist concept as lead of the World Health Organization's Safe Surgery Saves Lives initiative. "We have few examples where we've been able to demonstrate sustained success in quality improvement, and what Peter Pronovost has really demonstrated there is that there are simple interventions that can make a big difference and be sustained if the culture of medicine embraces them."
Kevin O'Reilly, Infection Rates Drop as Michigan Hospitals Turn to Checklists, Am. Med. News (Mar. 1, 2010).
FDA Recalls Flavor Enhancer Because of Salmonella Risk
The FDA said on Thursday that it expects to recall multiple food products made with a common flavor enhancer after one plant's supply was found to contain Salmonella. The flavor enhancer, called hydrolyzed vegetable protein (HVP), is used in thousands of packaged foods, according to the FDA.
No illnesses have been linked to the contamination to date, said officials from the FDA and the Centers for Disease Control and Prevention (CDC). The contamination was traced back to Las Vegas-based Basic Food Flavors, which provides HVP for many food companies that use the product in processed foods, including soups, sauces, chilis, stews, hot dogs, gravies, seasoned snack foods, dips, and dressings. Although officials would not give an estimate of how many companies might have used the contaminated HVP in their food products, they said that they expect the recall list to balloon in upcoming days.
FDA learned of the Salmonella contamination from a company that receives its HVP from Basic Food Flavors. The company had tested a shipment of HVP, discovered the contamination, and reported the information using the FDA's new online notification system, which was put in place after problems last year caused by Salmonella contamination in peanut butter.
FDA inspectors then collected and analyzed samples at Basic Food Flavor's Nevada facility and confirmed the presence of Salmonella in the company's processing equipment. FDA is telling food manufacturers that may have received Basic Food Flavor's contaminated HVP to destroy it or put it through a "kill step," such as heating the product, to destroy the bacteria.
Emily P. Walker, FDA Recalls Flavor Enhancer Because of Salmonella Risk, MedPage Today (Mar. 4, 2010).
Childhood Obesity Lower with Household Routines
Regular family dinners, adequate sleep, and limited television may prevent obesity in preschool-age children, according to a study published online February 8, 2010, in Pediatrics. Researchers found an almost 40% lower prevalence of obesity among four-year-olds who had regular family dinners at least six times a week, slept a minimum of 10.5 hours each weeknight, and watched no more than two hours of television or videos every weekday.
Researchers analyzed data from 8,550 U.S-born four-year-olds who were assessed in 2005 in the Early Childhood Longitudinal Study-Birth Cohort. The study was conducted by the National Center for Education Statistics to examine the learning environments, health, and development of young U.S. children. More than half of the children were said to have a family dinner at least six nights a week. The study found 57.5% slept
10.5 hours or more each weeknight, and 40.4% watched no more than two hours of TV and videos each weekday.
Researchers said 12.4% of the children lived in homes that practiced none of the routines. The study found each of the household routines was associated with a significantly lower prevalence of obesity. In households where all three routines were practiced, 14.3% of the children were obese. In homes with two routines, 15.8% were obese, and the rate was 20.9% in homes with one routine. About 25% of children were obese in homes with none of the routines.
Christine S. Moyer, Childhood Obesity Lower with Household Routines, Am. Med. News (Mar. 1, 2010).
FDA Tells IOM Panel of Shortfalls in Premarket Device Clearance Process
Officials from the FDA on March 1, 2010, told an Institute of Medicine (IOM) panel that the FDA lacks key oversight powers involving the 510(k) premarket clearance process for medical devices.
Echoing comments made at an FDA-run February 18, 2010, public meeting, officials said that they have concerns over the types of data needed to prove that a device is "substantially equivalent" to a predicate device as well as "safe and effective." The March 2, 2010, IOM meeting is part of an internal review of the 510(k) process running simultaneously with the one being conducted by a FDA working group. The agency commissioned the $1.3 million IOM review in September 2009. Panel members said two additional public meetings will be held over the summer, and a report is expected by 2011.
Jeffrey Shuren, newly appointed director of FDA's Center for Devices and Radiological Health, said at the IOM meeting that the two reviews are not mutually exclusive, and he is "happy to keep an open dialogue" between FDA's working group and the IOM panel.
A report by the FDA working group is expected by June.
Echoing comments made to FDA, industry stakeholders told the IOM panel that the 510(k) clearance program works, but the FDA needs to do a better job of keeping the process transparent and consistent. However, consumer safety advocate Diana Zuckerman, president of the research and advocacy group National Research Center for Women & Families, cited a soon-to-be-released study by her group showing that a significant number of highest-risk recalls (class I) are for 510(k) devices. Zuckerman told the panel that just because the 510(k) process is meant for moderate-risk devices does not mean patients' lives are not at risk, especially since the process is being used for implantable devices like surgical mesh.
Nathaniel Weixel, FDA Tells IOM Panel of Shortfalls in Premarket Device Clearance Process, BNA's Health Care Daily Report (Mar. 4, 2010) (note: registration is required to view this content).
Hopes for Alzheimer's Drug Are Dashed
It seemed somewhat unlikely, but in recent years an old Russian hay fever pill had become one of the world’s best hopes for treating the growing epidemic of Alzheimer’s disease.
But those hopes were dashed on Wednesday when the drug failed in its first late-stage clinical trial, dealing a blow not only to patients with Alzheimer's and their families but to the companies developing the treatment--a start-up in San Francisco called Medivation and the world's largest drug company, Pfizer.
The companies said in a statement that the drug, Dimebon, had shown virtually no effect after six months in treating the cognitive decline or behavioral problems associated with Alzheimer's when compared with a placebo. The result was somewhat surprising because in a smaller previous trial, Dimebon had shown what some experts characterized as better results than any of the drugs already approved for Alzheimer's disease. It seemed to improve cognitive function or at least stave off mental decline for about eighteen months, while the existing treatments do so for only about six months, experts said.
As recently as last week, an Alzheimer's researcher had said of Dimebon, "The clinical data is by far and away superior to anything that's ever been shown before." That researcher, Mark A. Smith of Case Western Reserve University, is a consultant to Medivation who is trying to figure out how the drug works. Still, some doctors and Wall Street investors had been a bit skeptical because that earlier trial had been conducted in Russia, making it hard to determine how the study was conducted. Also, the mechanism by which Dimebon worked was never clear.
Medivation shares lost two-thirds of their value Wednesday, plummeting to $13.10.
Before the results were announced, Medivation, which has no products on the market, had a market valuation of $1.3 billion based largely on the prospects for Dimebon.
The big questions now are whether the companies abandon other trials already under way for Dimebon or whether Pfizer itself, which has been paying 60% of the development costs, pulls out. Executives at both companies said they needed to further analyze the results before making such decisions.
Andrew Pollack, Hopes for Alzheimer's Drug Are Dashed, N.Y. TIMES (Mar. 3, 2010).
AHLA Teaching Hospital Updates are intended to provide quick summaries of cutting-edge issues of interest to teaching hospitals and their counsel. Additional information and more in-depth coverage on these topics may be available from AHLA Health Lawyers Weekly and appropriate AHLA Practice Groups.
*We would like to thank Leah Voigt, Esquire (Squire Sanders & Dempsey LLP, Washington, DC), for providing this week's update.