Time to Comment on the NEW FDA Guidelines for Social Media Use in Healthcare

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Draft Guidance for Industry on Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices; Availability
Draft Guidance for Industry on Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices; Availability: https://www.federalregister.gov/articles/2014/06/18/2014-14221/draft-guidance-for-industry-on-internetsocial-media-platforms-correcting-independent-third-party

The FDA has released new guidelines for how social media is used in healthcare. The University of Michigan had been involved in commenting on the original call for comments on this topic, and emphasized the potential impact of any guidelines on professional medical education and healthcare education more broadly. Those comments are available here

FDA-2009-N-0441 Docket Comments, University of Michigan Public Forum: http://www.slideshare.net/umhealthscienceslibraries/fda2009n0441-docket-comments-university-of-michigan-public-forum

Recent reviewers commenting on the new policy are encouraging people to consider these guidelines in the context of FDA actions, such as recent warning letters that explicitly comment upon Facebook “likes.”

FDA Warning Letters: Zarbee's (Facebook "Likes")
FDA: Warning Letters: 2014: Zarbee’s, Inc. 6/27/14: http://www.fda.gov/iceci/enforcementactions/warningletters/2014/ucm403255.htm

Remember, these are not yet cast in stone, as we are in a period of time when it is still possible to file comments on the docket for the guidelines. How could this impact on your work? How you teach students? Clinical trial recruitment? How you connect with patients, or patients connect with you? What about the impact on uses of social media for shaping future policy and grant funding? Even if you are not currently using social media, what about the future and how it might be used?

You can read more, find more links, and information on how to comment at this blogpost by THL Emerging Technologies Informationist, Patricia Anderson.

FDA On Social Media: Time to Pay Attention, Take Two http://etechlib.wordpress.com/2014/08/01/fda-on-social-media-time-to-pay-attention-take-two/

#FDA vs #23andMe, Take Two — Hashtags of the Week (HOTW): (Week of December 9, 2013)

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Last week we tracked opinions and responses with regards to the FDA warning letter sent to the direct-to-consumer personal genomics service, 23andMe. This week 23andMe officially announced that they are reducing the services they offer in response to the FDA’s warning letter.

23andMe, reduced

So what has been the reaction on Twitter? Let’s take a look at some of the most popular articles and examples of opinions.

FDA and New Food Safety Rules

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fdaWith a law that President Obama signed 2011, the Food and Drug Administration (FDA) will propose 5 new ruls to strengthen the nation’s food safety system.

According to the FDA’s website:

“The first two have been proposed and published for public comment:

  • Preventive Controls for Human Food: This rule sets safety requirements for facilities that process, package or store food for people. (There is a separate, upcoming rule for animal food.) The rule will require that food facilities implement “preventive controls,” a science-based set of measures intended to prevent foodborne illness.
  • Produce Safety: The food-safety law requires that science-based standards be set for the production and harvesting of fruits and vegetables, and FDA is proposing such standards for growing, harvesting, packing, and holding produce on farms…

…The rules still to come are:

  • Foreign Supplier Verification for Importers: This program will require importers to verify that foreign suppliers are following procedures that provide the same level of health protection as that required of domestic food producers. About 15 percent of the food consumed in the U.S. is imported, including about 49 percent of fresh fruit and 21 percent of vegetables.
  • Accredited Third Party Certification: The accreditation of third-party auditors would help ensure that food producers in other countries comply with U.S. food safety laws.
  • Preventive Controls for Animal Food: This is the implementation of preventive controls at animal food facilities that are similar to those proposed for human food.

The proposed rules have been published in the Federal Register, with a 120-day public-comment period. The rules are filed in FDA’s official docket at www.regulations.gov and can also be accessed at www.fda.gov/fsma.”

Read the full article at: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm334038.htm

Food and Drug Administration (FDA) Substance Registration System (SRS) added to PubMed records

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From the National Library of Medicine:

Unique Ingredient Identifiers (UNIIs) are being introduced into the Medical Subject Headings (MeSH) vocabulary starting with the 2013 MeSH Supplementary Concept Records (SCRs). The UNIIs are an integral part of the FDA Substance Registration System. They appear in several databases such as the Veterans Administration National Drug File Reference Terminology, the USP Dictionary of United States Adopted Names (USAN) and International Drug Names (INN), and the RxNorm database. Each UNII is a unique series of ten characters that includes a check digit to ensure data integrity.

FDA Approves First Medication to Reduce HIV Risk

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Reposted from the FDA Consumer Updates:

FDA Approves First Medication to Reduce HIV Risk

People diagnosed with HIV—the human immunodeficiency virus that without treatment develops into AIDS—take antiviral medications to control the infection that attacks their immune system.

Now, for the first time, adults who do not have HIV but are at risk of becoming infected can take a medication to reduce the risk of sexual transmission of the virus.

The Food and Drug Administration (FDA) has approved the new use of Truvada—to be taken once daily and used in combination with safer sex practices—to reduce the risk of sexually acquired HIV-1 infection in adults who do not have HIV but are at high risk of becoming infected. (HIV-1 is the most common form of HIV.)

n two large clinical trials, daily use of Truvada was shown to significantly reduce the risk of HIV infection

  • by 42 percent in a study sponsored by the National Institutes of Health (NIH) of about 2,500 HIV-negative gay and bisexual men and transgender women, and
  • by 75 percent in a study sponsored by the University of Washington of about 4,800 heterosexual couples in which one partner was HIV positive and the other was not.

Read the full news item here.

100K Genome Project

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Photo by hukuzatuna

The Food and Drug Administration has launched the 100K Genome Project whose goal is to create a public gene sequences database of the 100,000 bacteria that have been responsible for outbreaks of foodborne illnesses around the world.  In partnership with the University of California Davis and Agilent Technologies, the FDA hopes this database will:

  • “enable scientists in both the public and private sectors to develop tests that can identify the bacteria present in a sample within days or even hours.
  • help investigators discover the likely source of an outbreak.
  • greatly expand the pool of researchers able to develop software for the diagnosis and analysis of potential hazards that could lead to new methods of preventing and controlling outbreaks.”

Read the full story here.

Groups urge action on food safety law

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From the New York Times:

Ten consumer groups that helped promote a landmark food safety law passed in 2010 say the Obama administration is holding up the rules that would put it into effect, a delay they say could cost money and lives this summer, the peak season for food contamination outbreaks.

The Food Safety Modernization Act, which passed with broad bipartisan support, was the first major overhaul of the Food and Drug Administration’s food safety laws since the 1930s. It gives the agency, which is responsible for the safety of most of the country’s food supply, more control over food imports as well as broad new powers to set standards to prevent contamination of produce and processed food.

The law was motivated, in part, by the growing globalization of the nation’s food supply. Food imports have more than tripled over the past decade — about 80 percent of seafood is imported, for example — and currently, the F.D.A. inspects less than one pound in a million of imported foods.

But the F.D.A. rules that are needed to carry out the law have been under review by the Office of Management and Budget in the White House since December, and consumer health advocates say there has been no explanation for what they describe as a lengthy delay.

“It’s frankly a surprise to us,” said Erik D. Olson, director of food programs at the Pew Charitable Trusts, which was involved in promoting the legislation. “The administration was proud of this accomplishment, and having these things just sit there is quite a juxtaposition.”

Read the complete story here.

Health-care apps for smartphones pit FDA against tech industry

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From the Washington Post:

Three tries. More than two years. And roughly $150,000.

That’s what it took for MIM Software to get the Food and Drug Administration’s clearance for a smartphone application that physicians can use to view MRIs and other medical images.Three tries. More than two years. And roughly $150,000.

“It was 2008 when we first tried,” said Mark Cain, the Ohio firm’s chief technology officer. “They didn’t know what questions to ask and neither did we. . . . But at some point, they had to be thinking, ‘How many more people will be lined up behind these guys?’ ”

His was, in fact, among the first apps cleared by the FDA. And since then, medical applications have flooded onto millions of smartphones, offering consumers the chance to check their heart rate, identify a pill in their medicine cabinet or even scan moles for skin cancer. Soon, if a firm called AliveCor gets its way, they may even be able to get an EKG by pressing iPhone to chest.

The gee-whiz factor can both astonish and alarm.

A defect in apps that essentially turn your phone or tablet into a medical device could prove problematic or even life-threatening: The app may not work as it should. For instance, what if lighting or contrast issues distort an X-ray that’s viewed on an iPhone or iPad?

That’s why federal regulators lurched into action a year ago, offering their thinking on how to police this vast new frontier. Just as they were putting the finishing touches on a plan, lawmakers intervened. The Senate agreed to put the plan on hold after technology firms argued that heightened oversight would stifle innovation and cost jobs.

To read the complete article, click here.