Question: What are the FDA priorities for compounding for 2019?

Answer:
This week, we will look at the statement from FDA Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Anna Abram on new 2019 efforts to improve the quality of compounded drugs as they relate to compounding in a hospital pharmacy.

Statement from FDA Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Anna Abram on new 2019 efforts to improve the quality of compounded drugs

Statement (Opening)

Maintaining Quality Manufacturing and Compliance

Regulating Compounding from Bulk Drug Substances

Finalizing our Memorandum of Understanding with the States

Compounding by Hospital and Health Systems

Compounding by Hospital and Health Systems
“The agency recognizes that hospital and health system pharmacies are different than other pharmacies not owned by hospitals and from conventional manufacturers, and as such, have unique needs and challenges.

To that end, we plan to issue a revised draft guidance regarding hospital or health system compounding to provide further clarification on how the FDA intends to apply section 503A of the FD&C Act to drugs compounded at these facilities. Our revised policies will also provide guidance for hospital or health system pharmacies that might be considering registering as an outsourcing facility under section 503B.�

(Editor’s Note: Emphasis added.)

Additional Compounding Priorities

Editor’s Note: We will complete coverage of the FDA statements next week. Just a reminder, the complete statement can be obtained at:

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements
/ucm635182.htm

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

A $2-Million Drug is About to Hit the Market
A new treatment for an infant muscle-wasting disease is about to go on sale at a potential cost of $2 million—a record price tag likely to fuel the continuing scrutiny of how companies price their drugs and how insurers pay for them. Novartis AG has yet to set a price for the gene therapy called Zolgensma, but executives say the drug’s potential justifies such an expensive price.

(Editor’s Note: Pharmaceutical companies need to return to pricing based upon the cost of doing business (manufacturing, marketing, research, etc.), not some “pie-in-the-sky� guess so they can overcharge patients and pocket millions/billions of dollars!)
https://www.wsj.com/articles/a-2-million-drug-is-about-to-hit-the-market-11557221401

Study Shows More Than 500 Drugs’ Prices Were Hiked in the First Quarter of 2019
More than 500 drugs saw price hikes at the beginning of 2019, including price increases of nearly 3% for generics, according to a new report. Researchers at GoodRx found a 2.9% price hike across brand-name and generic drugs in the first quarter of 2019.

Drug pricing is one of the biggest healthcare issues in politics at present, with both state and federal officials laser-focused on the issue. Department of Health and Human Services Secretary Alex Azar has flagged lower drug prices as a key issue for the agency under his watch.
https://www.fiercehealthcare.com/keyword/goodrx

The 10 Most Prescribed Drugs in the U.S. in the First Quarter
The 10 most popular drugs during the first quarter of 2019 are all generics that cost less than $30 for a one-month supply. The 10 most prescribed drugs and their brand names are:

1. Atorvastatin (Lipitor)
2. Levothyroxine (Synthroid)
3. Lisinopril (Prinivil, Zestril)
4. Gabapentin (Neurontin)
5. Amlodipine (Norvasc)
6. Hydrocodone/acetaminophen (Vicodin, Norco)
7. Amoxicillin (Amoxil)
8. Omeprazole (Prilosec)
9. Metformin (Glucophage)
10. Losartan (Cozaar)

https://www.beckershospitalreview.com/pharmacy/10-most-prescribed-drugs-in-the-u-s-in-q1.html

Did You Know ...

…that Mother's Day is a celebration honoring the mother of the family, as well as motherhood, maternal bonds, and the influence of mothers in society? It is celebrated on various days in many parts of the world, most commonly in the months of March or May.

The modern holiday of Mother's Day was first celebrated in 1908, when Anna Jarvis held a memorial for her mother at St. Andrew's Methodist Church in Grafton, West Virginia. In 1914, Woodrow Wilson signed a proclamation designating Mother's Day, held in the U.S. on the second Sunday in May, as a national holiday to honor mothers.

Tip of the Week

Mother’s Day is a time to remember and celebrate our Mothers. It’s also interesting to look at some of the important Mothers in the Bible. These include Eve (the first mother), Sarah (Mother of Nations), Rebekah (Mother of Israel), Rahab of Jericho, Hannah (Samuel’s Mother), Abigal (a mother of good understanding and beautiful appearance), the Widow of Zarephath (Mother in Poverty), the Preacher’s Widow (in 2 Kings), the Great Shunammite Woman, Elizabeth (Older Mother), and Mary (Mother of Jesus). (Adapted from Acts & Facts, ICR, May 2017).

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Looking Back

That she could cook,
He had his doubts!
Until she creamed,
His bristle sprouts with
     Burma-Shave