This new FDA guidance describes two innovative approaches that may be useful considerations in demonstrating the safety and effectiveness for a nonprescription drug product in cases where the drug facts labeling (DFL) alone is not sufficient to ensure that the drug product can be used safely and effectively in a nonprescription setting.

• the development of labeling in addition to the DFL, and
• the implementation of additional conditions so that consumers appropriately self-select and use the product.

The FDA approves new drugs as prescription or nonprescription drug products under section 505 of the FD&C Act. A drug product must be dispensed by prescription if it is not safe to use except under the supervision of a practitioner licensed by law to administer the drug. If a drug product does not meet the criteria for prescription-only dispensing, it may be marketed as a nonprescription drug product.

The FDA determines whether the information submitted as part of a new drug application (NDA) for a nonprescription drug product is sufficient to ensure that the drug product is safe and effective for nonprescription use under the conditions prescribed, recommended, or suggested in its proposed labeling.

Self-selection studies considered by the FDA test whether consumers:

• can apply information in the drug product's labeling to their personal medical situations, and
• make correct decisions to use or not use the drug product, and
• actual use studies provide information on how consumers will use the drug product.

Also, nonprescription drug products must comply with applicable labeling requirements for over-the-counter (OTC) drug products. The DFL is intended to enable consumers to appropriately self-select and use the nonprescription drug product safely and effectively. In instances where the DFL alone would not be sufficient, an applicant may consider proposing innovative approaches, in addition to the DFL.

Next week, we will conclude by looking at the alternative innovative approaches the Agency is considering.

Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition

News

"Breakthrough Drugs": Are they really?
When federal regulators began designating certain drugs as "breakthrough" status in 2012, pharmaceutical-company interest exploded. The purpose was to speed up the approval of drugs for serious diseases when there was preliminary evidence that the new drugs were better than existing treatment options.

A new study published in JAMA delves deeply into the studies behind the flood of "breakthrough" therapies that have been approved by the FDA over the past six years. Their findings revealed that many of the trials that supported approval lacked the strongest kind of medical evidence, such as the following:

• No randomized trial was used for 40 percent of the approved drugs.
• Nearly half of the trials in this case did not include a placebo.
• In half of the studies, patients or their physicians were aware of who was getting the drug and who was not.
• Actual improvement in well-being was measured in only 22 percent of pivotal trials.

Many of these drugs come with high price tags that are financed with public funds through Medicare, Medicaid, and other programs, and the patients' point of view is not the only one of relevance. A consideration of cost is also reasonable from the point of view of taxpayers.
https://www.washingtonpost.com/news/to-your-health/wp/2018/07/17/the-truth-about-breakthrough-drugs/

https://www.reuters.com/article/us-health-drugsafety/evidence-to-support-breakthrough-drugs-often-very-limited-study-idUSKBN1K72HC

Did You Know ...

�that Winston Churchill said "An appeaser is one who feeds a crocodile, hoping it will eat him last!"?

Tip of the Week

We generally try to get along with everyone. However, in some instances where one has strong values and feelings, it is necessary to "speak up!" Otherwise, we hear that "everyone agrees with what is said," when many, if not most, do not agree but are simply being polite�while the crocodile is licking his lips!

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Looking Back

Drove too long,
Driver snoozing,
What happened next,
Is not amusing!
     Burma Shave