The FDA and industry has done an excellent job in identifying and reducing Medical Product Shortages. Please update yourself by reading the information on FDA's website under CDER/Drug Shortages. We need to find solutions (not more reasons) for the shortages.
Project one: One of the most important shortages is for sterile injectable oncology drugs (medically necessary drugs) particularly manufactured by generic companies. In the next few days, I will post thoughts, comments, questions for your input so we can arrive at a faster solution.
Initially, I do not see answers to:
1. What are the specific quality issues?
2. A list of FDA guidances that can be used to resolve this situation.
2. Who are the partners that will solve the problem
3. What is the win-win solution?
4. Create better incentives (other than saving lives)
Feb 6 - from Gene
ReplyDeleteHere are my additional comments to those of Feb 5 in preparation for the solution or solutions which I want to publish this week. I will forward (invite) this info to a group of people on my list for comments/solutions. Please forward to those on your list who will provide solutions (let's avoid long discussions)
1. Estblish Partnerships – domestic and foreign (need to establish)
2. Prevent before occurring (onsite audit)
a. Audit suppliers (raw materials and direct material contact e.g. vial, ampoules, pouche) etc.
3. Identify top three injectable companies (that hold 71% of the market by volume)
a. Most sterile injectables have one manufacturer that produces at least 90% (identify the company.)
b. Identify other firms that can take up the slack
c. Identify the oncology injectables that are in short supply
4. Legislation (to read and see if enacted; if not, why not)-
a. Read: Senator Amy Klobuchar’s
5. Major Quality problems with sterile injectable (how to avoid occurrence in the first place):
a. Glass shards
b. Metal filings
c. Fungal contamination
d. Other
6. Notification
Once I receive your comments, I will collate and propose the final solution or solutions
My initial findings for comments:
DeleteI reviewed one of the FDAs drug shortage lists from last week (see attached list which I converted to excel).
The FDAs list is updated on regular bases.
• From that list I created a separate list of products that are used in chemotherapy/oncology (see attached list). Note- one drug, Mesna, is used to treat the side effects from chemotherapy.
• The FDA list should also be offered in excel to better obtain statistical data.
• The excel list should be sortable via the auto filter (which I cannot do after converting to excel).
• I believe the initial format needs to change to allow for proper sorting.
• The list should include products indications e.g. chemotherapy, oncology,
• The list should include the health risk factor.
• Approximately 8% of the products on the drug shortage list are used for chemotherapy/oncology. Let’s work together to reduce and maintain the list at 0%.
• The companies involved in the chemotherapy/oncology-drug shortage are:
o APP (with 8 issues for multiple products)
o Bedford (some products suspended at Ben Venue) (with 6 issues for multiple products)
o TEVA (with 5 issues for multiple products)
o Mylan (with 2 issues for multiple products)
o Sargent (with 2 issues for multiple products)
o Hospira (with 2 issues for multiple products)
o Sandoz (with 2 issues for multiple products)
o Accord Healthcare (with 2 issues for multiple products)
o Baxter (with 1 issue)
o Lundbeck (with 1 issue)
o BMS (with 1 issue)
• The main but very general reasons for the drug shortage include:
• Increased demand (15 notations)
• Manufacturing delays (no details offered by FDA) (12 notations)
• Discontinuation of size (1 notation)
• It should be noted that if the brand product is available, the cost is generally much higher than the generic AND some health insurance companies will not pay if a generic version is available.
• Which are the pending ANDAs for chemotherapy/oncology products? Let’s speed up the approval process on those.
• We need to include a list of company names that have the products available (brand or generic).
Accordingly, here are my additional comments for our consideration:
1. What are the specific quality issues?
a. FDA only lists “manufacturing delays”
2. Need a list of FDA guidances that can be used to resolve this situation.
3. Who are the partners that will solve the problem?
a. Provide the group with a list of manufacturers that can fill in the void.
4. What is the win-win solution?
a. Make sure all high level decision makers have the facts so they can offer solutions quickly.
5. Create better incentives (other than saving lives)
6. Establish Partnerships – domestic and foreign
7. Prevent before occurring (onsite audit);
a. Audit suppliers (raw materials and direct material contact e.g. vial,
ampoules, pouche) etc.
8. Identify top three injectable companies (that hold 71% of the market by volume)
9. Most sterile injectables have one manufacturer that produces at
least 90% (identify the company.)
10. Identify other firms that can take up the slack
11. Identify the oncology injectables that are in short supply
a. Refer to attached list
12. Legislation (to read and see if enacted; if not, why not)-
a. Read: Senator Amy Klobuchar’s proposed bill
b. Keep legislatures in the email loop
13. Major Quality problems with sterile injectable (how to avoid occurrence in the first place):
a. Glass shards
b. Metal filings
c. Fungal contamination
d. Other
14. Notification to industry on status
15. Status of any pending ANDAs for these products?
Update 3/19/12
ReplyDeleteBased on the updates below, a moderate amount of success has been achieved. At least we are succeeding in getting our message across that we have a major problem that needs to be resolved quickly. I just learned that the Canadian authorities have a mechanism in place to reduce their shortage. Obviously any mechanism must result in the use of safe and effective drugs.
Here's the updates: LET'S HEAR FROM YOU!
On 3/16/12 I wrote to President Obama the following:
March 6, 2012
Subject: U.S. Drug Shortage Problem
Dear President Obama:
This is regarding the U.S. Drug shortage problem. We need to save lives.
In order to help reduce the shortage, in the beginning of February I decided to apply my forty years of pharmaceutical experience with particular attention on reducing the drug shortage for injectable products used for chemotherapy/oncology. Approximately 8% of the injectable products on the FDA’s drug shortage list from the week of January 30, 2012 are used for chemotherapy/oncology treatment.
I created a blog (http://geneander.blogspot.com), then created a task force and contacted private, public and various other people and organizations including newspapers and offered suggestions on reducing and/or stopping the shortage.
In order to see what progress had been made, I compared the FDA’s Drug Shortage list from late January to a current list. Unfortunately and with much disappointment I do not see much progress.
On a positive note, FDA reached out to enhance the supply of Methotrexate/Doxil by starting to import a drug called Lipodox from an Indian company. FDA also just published a new draft Guideline entitled: “Notification to FDA of Issues that May Result in a Prescription Drug or Biological Product Shortage.”
TEVA has made small improvements in the supply of Bleomycin, Etoposide and has ample inventory of Fluorouracil. Baxter has inventory of Mesna along with Hospira improved inventory of same
Senator Amy Klobuchar’s introduced a bill in February 7, 2011 (S.296) to amend the Federal FD&C Act.
Unfortunately, I believe, that both the FDA’s draft guideline and Senator Amy Klobuchar’s bill once implemented (which could be many months or years away) will not effectively reduce the shortage because the pharmaceutical industry will not comply fast enough.
I believe, President Obama, than an executive order is necessary. In preparation of such an order, I would suggest that you first have a group meeting with executives from the pharmaceutical industry and government personnel to help develop partnerships to create a win-win scenario (develop incentives). I trust this can be done quickly. I will be glad to assist.
Respectfully submitted,
Gene Ander
On 3/14 -
President Obama responded by saying:
Dear Gene:
Thank you for writing and sharing your perspective. I appreciate your taking the time to offer your comments on the issues facing our Nation.
My Administration will continue to take bold action to secure a brighter future for our country. In our democracy, it is not necessary for everyone to always agree. But we must all remain engaged and committed to work together as we build a stronger, fairer, and more prosperous America.
Please know the trials and triumphs of Americans like you motivate my Administration to continue working to overcome the challenges before us. To learn more about my Administration or to contact me in the future, please visit: www.WhiteHouse.gov.
Thank you, again, for writing.
Sincerely,
Barack Obama
Also on 3/16, I contacted the news media and awaiting their response. In addition, I've contacted captains of industry and awaiting their response.