MediMap (INOVA Genomics Laboratory) warned and other regulatory news

(May 12, 2019)

1. Beware of medication-compatibility genetics testing claims

Last month, the FDA issued a warning letter to a genetics testing unit of a large northern Virginia hospital organization, INOVA Health Care System. The FDA claimed that INOVA Genomics Laboratory was "illegally marketing certain genetic tests that have not been reviewed by the FDA for safety and effectiveness."

The tests claimed to predict patients' responses to medications based on genetic variants. INOVA had expanded its "MediMap" genomics testing service to include a new service as a standard part of its maternity care: genetic tests for newborns claiming to predict medication compatibility. That test, called "MediMap Baby," was hailed by some as being cutting-edge and perhaps a signal of what was to come. However, since receiving the warning letter, INOVA has removed all MediMap information from its web site and no longer offers the MediMap testing service.

Most currently available genetics compatibility testing has been centered on antidepressants and psychiatric drugs. Most medications, even if approved for pediatric use, do not generally include infants.To read the FDA warning letter to INOVA, click here:

AskaPatient article on drug suitability testing:

2. Sleep medications to include a black box warning for risk of bizarre and dangerous behavior

Some categories of "Z" drugs or insomnia medications are known to have side effects, but recently the FDA announced that the risk of "complex sleep behaviors" leading to serious injury or death is great enough to warrant a black box warning on the drug labels.

The FDA recommends that if a person has a "complex sleep behavior" after taking one of these drugs, they should notify their doctor and discontinue taking the drug.

Drugs affected by new black box warning:
1. zolpidem tartrate
(Brand names include Ambien, Ambien CR, Edluar, Intermezzo, and Zolpimist)
2. eszopiclone
(Brand name Lunesta)
3. zaleplon
(Brand name Sonata)

What the FDA calls "complex sleep behaviors" is only defined by examples, which include:
"sleepwalking, sleep driving, and engaging in other activities while not fully awake."
Also, while the serious consequences of the complex sleep behaviors are called "rare," many examples of such behaviors, which often the patient does not remember, are reported on sites like AskaPatient and also in the FDA's FAERS (Adverse Event Reporting System) database.
FDA press release on strengthened warnings for sleep medications

3. Drug prices to be disclosed in TV commercials

On Friday, May 10, 2019, the Health and Human Services Department (HHS) announced a plan to require drug pricing transparency in direct-to-consumer advertising. (See the May 10, 2019 Federal register announcement ( ). The plan calls for television commercials advertising prescription drugs that are reimbursed by Medicare of Medicaid to provide the list price if the drug costs more than $35 for a month's supply.

Kaiser Health News provides some sample monthly prices for heavily advertised drugs: Humira ($5,846); Xeljanz ($4,914); Lyrica ($1,070); Cosentyx ($11,309); Taltz ($6,193); Chantix ($515). Consumers might be surprised at how expensive these drugs are.

Given that drug prices have been escalating in recent years, perhaps improved transparency will help control price spikes. The pharmaceutical industry, which is opposed to the new plan, points out that the "point-of-sale" out-of-pocket costs for patients is often lower than list price. Nevertheless, insurance payouts and taxpayer-funded government payouts by Medicare and Medicaid are affected by list prices.

Physicians and consumers would, for the most part, prefer that prescription drugs NOT be marketed directly to consumers. Since a ban on such advertisements is not likely anytime soon in the U.S., at a minimum they want transparency and clarity in drug commercials. Here are some related polls from our web site. Click link to read poll results, comments, and links to related articles.

* A 2014 poll suggested most people do not think that pharmaceutical industry should be allowed to produce direct-to-consumer ads in the first place.

*  Another 2014 poll revealed that 70% of respondents found television commercials for prescription drugs to be confusing or misleading.

* A 2017 poll asked respondents about a proposal to allow abbreviated risk warnings in TV commercials.

* In our Fall 2019 poll, 90% of respondents thought it was a good idea to include drug prices in television commercials.