In surprise announcement, FDA determines that cafepharma's website is a drug and company must submit an NDA

March 30, 2018

Today the FDA announced that the agency has determined that the site is in fact a drug and will require the company to submit a full new drug application (NDA) to continue to produce, market and distribute the site. The announcement further stated that the addictive nature of the site would likely require the site to be classified a schedule II drug. This would make the site only available by prescription to the most serious patients. It would also impose onerous reporting standards on both prescribing physicians and Cafepharma, Inc.

While cafepharma and its millions of users were stunned by the announcement, PhRMA (The Pharmaceutical Research and Manufacturers of America) applauded the move. A spokesperson said, “We have been petitioning the agency for years to limit access to this dangerous product. It is good to see the FDA finally taking action.” In support of the FDA's announcement PhRMA cited a number of posts on cafepharma's message boards where users claim to be addicted to the site.

“It doesn't get much more clear than that,” the spokesperson said.

The FDA made the announcement during a morning press conference held by its commissioner. Reporters noted that an NDA approval can take years and cost almost a billion dollars. They also pointed out that NDA's required many studies including efficacy, dissolution rate, bioavailability, etc. How, they asked, could such studies be conducted on a website?

“It's going to be pretty rough,” the commissioner admitted.

Cafepharma stated that it would immediately file a Citizen Petition with the FDA declaring that the site was in no way a drug, but merely a unique and informative website - something more along the lines of a daily dietary supplement.

By now we hope everyone has realized that this is a satirical piece for April Fools Day. We hope you enjoyed it and we hope you have a great weekend.

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