The FDA is clear­ly keep­ing up with the Kar­dashi­ans as its Of­fice of Pre­scrip­tion Drug Pro­mo­tion (OPDP) raised con­cerns that Khloé Kar­dashi­an’s pro­mo­tion­al video for a Bio­haven Phar­ma­ceu­ti­cals mi­graine drug made false claims about quick re­lief in as lit­tle as 15 min­utes.

In re­al­i­ty, OPDP said in its first un­ti­tled let­ter of the year, clin­i­cal work to sup­port the drug, known as Nurtec ODT, be­gan mea­sur­ing how it works two hours af­ter dos­ing.

“Claims that Nurtec ODT pro­vides re­lief in 15-30 min­utes are not sup­port­ed by the clin­i­cal tri­al da­ta,” the FDA said in its let­ter re­leased Tues­day.

The video, which orig­i­nal­ly aired on ABC’s “The View” last sum­mer, al­so claims that Nurtec ODT is more ef­fec­tive than oth­er mi­graine drugs and a “gamechang­er.”

Again, the FDA makes clear that these com­par­a­tive claims are mis­lead­ing be­cause Bio­haven has not demon­strat­ed that Nurtec ODT is clin­i­cal­ly su­pe­ri­or to or more ef­fec­tive than oth­er pre­scrip­tion and over-the-counter drugs. The com­pa­ny has 15 work­ing days to re­spond to the FDA.

“Bio­haven is work­ing close­ly with the FDA to eval­u­ate their com­ments and re­spond,” the com­pa­ny said in an SEC fil­ing on Tues­day.

This isn’t the first run-in be­tween the FDA and the Kar­dashi­ans over their pro­mo­tion of drugs. Khloé’s sis­ter Kim pro­mot­ed Duch­es­nay’s morn­ing sick­ness drug Di­clegis on In­sta­gram back in 2015 and the FDA slammed the com­pa­ny with a warn­ing let­ter for not dis­clos­ing enough risk in­for­ma­tion in the post.

The FDA is offering more of an explanation of the guardrails around its program that may soon allow states to import prescription drugs in some select circumstances from Canada, but only if such imports will result in significant cost reductions for consumers.

While the agency has yet to sign off on any of the 5 state plans in the works so far, and PhRMA’s suit to block the Trump-era rule allowing such imports is stalled, the new Q&A guidance spells out the various restrictions that states will have to abide by, potentially signaling that a state approval is coming.

New data from HHS show that more than 162,000 courses of Pfizer’s Covid-19 antiviral Paxlovid were administered across the US over the past week, continuing a streak of increased usage of the pill, and signaling not only rising case numbers but more awareness of how to access it.

In comparison to this week, about 670,000 courses of the Pfizer pill have been administered across the first five months since Paxlovid has been on the US market, averaging about 33,000 courses administered per week in that time.

Leading the way to increase access to cheaper drugs worldwide, Pfizer said Wednesday it will provide all current and future patent-protected medicines and vaccines available in the US or EU on a not-for-profit basis to about 1.2 billion people in 45 lower-income countries.

Rwanda, Ghana, Malawi, Senegal and Uganda are the first five countries to sign on to this accord, which will also seek to blaze new paths for quick and efficient regulatory and procurement processes to reduce the usual delays in making new medicines and vaccines available in these countries.

Vanda Pharmaceuticals is making a name for itself, at least in terms of suing the FDA.

The DC-headquartered firm on Monday filed its latest suit against the agency, with the company raising concerns over the FDA’s failure to grant a fast track designation for Vanda’s potential chronic digestive disorder drug tradipitant, which is a neurokinin 1 receptor antagonist.

Specifically, Vanda said FDA’s “essential point” in its one-page denial letter on the designation pointed to “the lack of necessary safety data,” which was “inconsistent with the criteria for … Fast Track designation.”