Question: Why were the four drugs, Oxitriptan, Piracetam, Silver Protein Mild, and Tranilast, NOT approved for inclusion on the Bulks List?

Answer:

Note: As a follow up to last week's Newsletter, in this Newsletter, we will cover the reasons as provided by the FDA why "Piracetam" was not included on the Bulks List.

PIRACETAM
Piracetam was evaluated as a treatment for enhancing cognitive skills in treating a variety of cognitive disorders, including Alzheimer's disease. It has also been studied for treatment of coagulation disorders and vertigo. It is well characterized physically and chemically. Piracetam is approved in the United Kingdom (UK) as a prescription drug for the adjunctive treatment of cortical myoclonus. The labeling of the UK product identifies that the drug is renally excreted, that the dosage should be adjusted in the presence of renal disease, and that it is contraindicated in end-stage renal disease. Piracetam acts by multiple mechanisms to prolong bleeding time and is, therefore, not recommended for use by individuals with medical conditions that prolong bleeding time or that are taking concomitant anticoagulants or other medications that prolong bleeding (Ref. 9 [in the FDA's original document]). Piracetam is not recommended for women who are pregnant, planning to become pregnant, or breastfeeding because, according to the UK product's labeling, the drug has been shown to cross the placenta and be excreted in human milk. It is also recommended that individuals required to restrict their salt intake avoid piracetam (id. [in the FDA's original document]).

Piracetam was assessed for the treatment of mild cognitive impairment, a potential component of Alzheimer's disease, in a large, well-conducted, controlled clinical trial that failed to demonstrate efficacy. Studies of the efficacy of piracetam for other indications have been inconclusive, many of which were poorly designed or executed, or used flawed statistical methods to analyze the results. Piracetam's regulatory approval in the UK for the treatment of cortical myoclonus, which is not among the uses for which piracetam was nominated, was based on a single center, retrospective review of 40 patients treated with piracetam (id. [in the FDA's original document]). The FDA-approved products are available for treatment of the conditions and conditions related to those for which piracetam was nominated, for example, Alzheimer's disease, which is frequently preceded by mild cognitive impairment. Regarding historical use, piracetam has been available for approximately 40 years.

On balance, the physiochemical characteristics, safety concerns, inconclusive evidence of effectiveness, and historical use of piracetam weigh against inclusion of this substance on the list. In particular, the Agency's [FDA's] proposal regarding this substance is based on the limited evidence of benefit associated with piracetam, the seriousness of the conditions for which piracetam was nominated to be used, and the availability of safe and effective FDA-approved medications for many of these uses. The FDA proposed to the PCAC that this substance not be included on the 503A Bulks List (Ref. 8 [in the FDA's original document]). At its meeting on February 24, 2015, the PCAC voted not to include piracetam on the list (Ref. 3 [in the FDA's original document]). The proposed rule would not place piracetam on the 503A Bulks List.

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

FDA Commissioner Gottlieb Resigns
FDA Commissioner Scott Gottlieb has resigned; the 46-year-old physician, former venture capitalist and drug consultant will leave in about a month. Gottlieb, who has been commuting weekly to Washington from his home in Connecticut, said he wants to spend more time with his family. The 46-year-old physician, millionaire, and cancer survivor known for a self-assured, sometimes brash, manner lives in Westport with his wife and three daughters - 9-year-old twins and a 5-year-old.

"It was a very hard decision," Gottlieb said in an interview. "This is the best job I will ever have. I'm leaving because I need to spend time with my family." The resignation was not sought by the White House. A senior White House official said Gottlieb had spoken to President Trump, and that the president liked the FDA chief and did not want him to leave.
https://www.washingtonpost.com/health/2019/03/05/fda-commissioner-gottlieb-who-raised-alarms-about-teen-vaping-resigns/

Pharmacy Owners Rally in Albany
Hundreds of neighborhood pharmacy owners from across New York rallied in Albany against the middlemen at the center of the state’s broken prescription drug-distribution system. The pharmacy owners called on lawmakers to enact regulations requiring transparency for the pharmacy benefit managers (PBMs) - and new protections for patients, taxpayers, and neighborhood pharmacies.

"New York's prescription drug distribution system is broken, and it is time to fix it," said Elizabeth Lasky, executive director of the Pharmacists Society of the State of New York (PSSNY). "Prescription drug middlemen are rigging prices, eliminating patient choice, ripping off taxpayers, and destroying neighborhood pharmacies. We urge our elected representatives in Albany to act now by introducing common sense regulations to protect patients, taxpayers, and neighborhood pharmacies."
https://www.chaindrugreview.com/pharmacy-owners-rally-in-albany/

Prices Different Between Small and Large Pharmacies
Consumers could save up to $5,400 a year by price shopping for their medications, according to a new study published by the U.S. Public Interest Research Group. For its survey, the research group called more than 250 pharmacies in diverse cities and regions in 11 states to determine the price uninsured patients would pay for 12 drugs that treat asthma, high blood pressure, and diabetes.
https://www.beckershospitalreview.com/pharmacy/smaller-independent-pharmacies-offer-drugs-up-to-840-cheaper-study-finds.html

Did You Know ...

...that Pete Rose said the following?

"My father taught me that the only way you can make good at anything is...to practice, and then practice some more!"

Tip of the Week

If one has never mastered something, whether it is music, sports, entertaining, professional practice, a trade, vocation, or other, one can never appreciate the time, study, sacrifice, and dedication required to "make good at something." Nothing comes easy, and one should never expect to start at the top. If one works hard for something, they tend to have a deeper appreciation for it.

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Looking Back

Spread it on,
And lightly too,
Shave it off,
That's all...you're through!
     Burma Shave