FDA Social Meeting Safety Late Morning Key Points

Seinfeld said it best, "yada, yada, yada." Most safety presentations were again more of the same.

Three main points came across loud and clear this morning:

1. Encourage restraint by FDA (give industry time to work with you and experiment)
2. Allow innovation to take root (innovation and technology can solve a lot of the problems with safety concerns)
3. Take the first step and begin to establish new guidelines
   

Jonathan from Bridge, and Zen Chu from Accelerated Medical Ventures shared some interesting perspectives on the safety issue/concerns.

Bridge Worldwide/ Dose of Digital

• We will never know (presently) true identities of individuals (nicknames, 'handles' and other present fields make it impossible to know if you are truly who you say you are
  
• Don't try to sleuth the Internet. If you can't identify the patient, they do not meet the criteria. Evaluate to what degree you feel you need to responsibly engage.
• Consider tools like iGuard (available on ConsumerMedSafety.org) for patients to enter their medications, check for possible drug interactions, and post comments and questions within one system so reports can be easily followed.

Accelerated Medical Ventures
Patients who are not engaged to not comply. Over 50% of non-compliant patients actually choose to be non compliant for one of 3 reasons:

• They feel they do not need the medication
• They fear having side effects and avoid taking the medication
• Medication simply costs too much

Zen Chu put it best by describing this as "A failure of the doctor-patient [and industry] relationship." He likened the doctor discussion about safety to be equal to reading the fair balance, as HCPs are severely time limited and recite what is in the fair balance.

A wonderful concept he shared was a proposal to test different balance and safety messaging on different devices to see which work best on what mediums/devices. "Dumb" phones (you know the ones your parents use) can handle different communications than smartphone. And, the Web is entirely different altogether.

As a marketer I LOVE his idea....test different safety messages, based on a matrix of devices to determine the best methodology. Hello? FDA is all about data. What better way to set guidelines moving forward than to test and see what works? Establish device-specific guidelines, based on the results of the test above.

If we can conduct thousands of clinical trials (safely I might add), then most certainly we can test safety messaging safely and improve patient compliance and health outcomes.

Zen offered 5 suggestions that were some of the most interesting of the morning:

1. FDA should exercise restraint. Don't be so quick to issue warning letters. Open dialogue and discuss things before wielding the pen and paper too quick.
2. DDMAC should provide guidelines for pre- and post-script marketing. Meaning the safety message to patient before they fill their first script should be different than once they are on drug.
3. FDA needs to establish a new media and technology advisory board.
4. FDA needs a dedicated team and strategy for electronic/social media marketing regulations
5. Guidance needs to be more frequent (more than every 10 years!)