President Obama to order FDA to help reduce drug shortages

[cal04]

Source: Associated Press

Acting once again ahead of Congress, President Barack Obama is directing the Food and Drug Administration to take steps to reduce drug shortages, an escalating problem that has placed patients at risk and raised the possibility of price gouging.

A White House official said the president planned to sign an executive order Monday instructing the FDA to take action. The order would be the latest in the president's campaign to move on initiatives that do not require congressional approval.

Last year, the FDA reported 178 drug shortages, and the agency says it continues to see an increase in shortages this year. These scarcities tend to affect cancer drugs, anesthetics, drugs used in emergency medicine, and electrolytes needed for intravenous feeding.

Obama also will announce his support for House and Senate legislation that would require drug makers to notify the FDA six months ahead of a potential shortage, the official said. Under current regulations, drug manufactures are only required to notify the FDA if medically necessary drugs are being discontinued. Notification of shortages is strictly voluntary.

Read more: http://www.google.com/hostednews/ap/article/ALeqM5h_tjkifWpscYf9xkN4gsMP-abubQ?docId=8183bf8f4113420aa4c922fd4c5f9260

[SkyDaddy7]

1. "Notification of shortages is strictly voluntary."

I think that describes the entire US Regulatory System...VOLUNTARY!

[No Elephants]

5. Right. No one wants to distract the job creators from creating all those jobs they've been busy

not creating.

[Demeter]

2. And what exactly is the FDA supposed to do about it?

Allow dangerous drugs on the market?

Or just maybe, allow importation of safe and effective drugs from Canada and Western Europe?

Why doesn't he sic the Justice department on Pfizer instead, and bust the drug cartel which has been systematically buying up and shutting down the competition?

(read the link...what a load of crap. How can they call this reporting?)

[Divernan]

3. This "executive order" is a PR stunt which does NOTHING to alleviate the problem.

I quote from the article: "The FDA does not have authority to force drug makers to continue production of a drug."

There is no mention or explanation or detail offered as to how this "executive order" in any manner changes the rules and regulations under which the FDA operates. IF there is ANYTHING the FDA can ALREADY do to "take action", nothing in the Executive Order changes that, and Obama need only have simply ordered the FDA to more aggressively pursue and enforce the existing rules and regulations.

It seems clear that the problem lies with Big Pharma pursuing Big Profits.

What, in practicality, can Obama do? Simple. He can publicly call out all his Big Pharma donors and supporters & publicly shame them into upping their production of drugs and continuing production of drugs on which they're not making as much profit.

And what's with "notifying the FDA if medically necessary drugs are being discontinued"? What is the FDA expected or empowered to do at that point? Manufacture the drugs itself? Authorize importation of foreign drugs?

If the proposed legislation in the House and Senate IS passed, so what? What can a customer do when it's announced 6 months out that a shortage is coming? Start hoarding the medication? That will only bring about the shortage sooner.

[No Elephants]

4. I don't suppose the drug reimportation bill the WH killed would have helped

cure drug shortages that lead to price gouging.

Geebus. Aren't research grants, crazy profits and the bailouts under Part D of Medicare and the Health Care Reform bill enough for the drug companies?

And this is voluntary anyway. Whooptie frickin' do.


"The FDA says major causes of drug shortages are quality or manufacturing problems, or delays in receiving components from suppliers. Drug makers also discontinue certain drugs in favor of newer medications that are more profitable. The FDA does not have authority to force drug makers to continue production of a drug."

If they can't order continuation of production, can they at least cancel the patent, so someone can make it, if they wish?

[bemildred]

6. Oooooh yeah, put a Tiger Team on it, form a committee. nt

[Divernan]

7. K&R

[Akoto]

8. Obama orders FDA to help reduce drug shortages

Source: Associated Press

WASHINGTON (AP) -- President Barack Obama is directing the Food and Drug Administration to take steps to reduce drug shortages, action he says will help stop a "slow-rolling problem" that puts patients at risk and raises the potential for price gouging.

Obama signed an executive order in the Oval Office on Monday instructing the FDA to take action in three areas: broadening its reporting of potential drug shortages; accelerating reviews of applications to change production of drugs facing potential shortages; and giving the Justice Department more information about possible instances of collusion or price gouging.

Patient deaths have been blamed on the shortages, which tend to affect cancer drugs, anesthetics, drugs used in emergency medicine, and electrolytes needed for intravenous feeding. Hospitals have been forced to buy from secondary suppliers at huge markups. Surgeries and cancer treatments have been delayed.

"Even though the FDA has successfully prevented an actual crisis, this is one of those slow-rolling problems that could end up resulting in disaster for patients and health care facilities all over the country," Obama said.

Read more: http://hosted.ap.org/dynamic/stories/U/US_OBAMA_FDA?SITE=WILAC&SECTION=HOME&TEMPLATE=DEFAULT

[DreamSmoker]

9. Obama snaps his fingers and the DEA jumps????

Yet screw those who need the Medical Cannabis just to get through each day...

[valerief]

10. Why now? Why not when the shortage was first announced? nt

[Divernan]

11. This is a duplicate to cal04's LBN post earlier today, which made it to the greatest page.

Of course, the responses really tore into Obama.

5043327

[Divernan]

12. This executive order is a hollow sham, put out for PR

This "executive order" is a PR stunt which does NOTHING to alleviate the problem.
Posted earlier on the first LBN thread on this story.

I quote from the article: "The FDA does not have authority to force drug makers to continue production of a drug."

There is no mention or explanation or detail offered as to how this "executive order" in any manner changes the rules and regulations under which the FDA operates. IF there is ANYTHING the FDA can ALREADY do to "take action", nothing in the Executive Order changes that, and Obama need only have simply ordered the FDA to more aggressively pursue and enforce the existing rules and regulations.

It seems clear that the problem lies with Big Pharma pursuing Big Profits.

What, in practicality, can Obama do? Simple. He can publicly call out all his Big Pharma donors and supporters & publicly shame them into upping their production of drugs and continuing production of drugs on which they're not making as much profit.

And what's with "notifying the FDA if medically necessary drugs are being discontinued"? What is the FDA expected or empowered to do at that point? Manufacture the drugs itself? Authorize importation of foreign drugs?

If the proposed legislation in the House and Senate IS passed, so what? What can a customer do when it's announced 6 months out that a shortage is coming? Start hoarding the medication? That will only bring about the shortage sooner.

[Divernan]

13. Demeter's comment on earlier thread: "And what exactly is the FDA supposed to do about it?

Edited on Mon Oct-31-11 06:46 AM by Demeter
Allow dangerous drugs on the market?

Or just maybe, allow importation of safe and effective drugs from Canada and Western Europe?

Why doesn't he sic the Justice department on Pfizer instead, and bust the drug cartel which has been systematically buying up and shutting down the competition?

(read the link...what a load of crap. How can they call this reporting?)

[Divernan]

14. From No Elephants: "Don't suppose the drug reimportation bill the WH killed would have helped.

No Elephants Donating Member (1000+ posts) Click to send private message to this author Click to view this author's profile Click to add this author to your buddy list Click to add this author to your Ignore list Mon Oct-31-11 08:04 AM
Response to Original message
4. I don't suppose the drug reimportation bill the WH killed would have helped

Edited on Mon Oct-31-11 08:13 AM by No Elephants
cure drug shortages that lead to price gouging.

Geebus. Aren't research grants, crazy profits and the bailouts under Part D of Medicare and the Health Care Reform bill enough for the drug companies?

And this is voluntary anyway. Whooptie frickin' do.


"The FDA says major causes of drug shortages are quality or manufacturing problems, or delays in receiving components from suppliers. Drug makers also discontinue certain drugs in favor of newer medications that are more profitable. The FDA does not have authority to force drug makers to continue production of a drug."

If they can't order continuation of production, can they at least cancel the patent, so someone can make it, if they wish?
90% v. 10%, not R v. D. If you misdiagnose, you'll likely mistreat. If you mistreat, improvement is less likely. Koch = Evil
Alert

[No Elephants]

16. Hey, Divernan! Watch out! I just hired Right Haven's lawyer!

j/k I/m flattered.

[Tx4obama]

15. So, there was a segment on this on MSNBC. A $12 vile of cancer medicine selliing for like $900

Who's show was it on?
Hardball?
Last Word?
Maddow?

This is a BIG deal and should be exposed.

President Obama is doing a GOOD thing trying to solve this problem.

On the segment they also said that since there is a shortage of the drug that fights the cancer the research teams can't study 'new' drugs because the patients taking the 'older' drugs are few and far between.

[No Elephants]

17. Just got a price on Nexium last night. For someone with no insurance $562 for one month.

For those who don't know, Nexium blocks stomach acid, like Tums on steroids in capsule form.

Not rocket science.

If you have severe gut problems, though, it could save you from serious damage from acid. And, if your problems cause vomiting, might save you from esophageal cancer, damaging your teeth, etc.

Still under patent, I think, but far from a new drug. It's been around since at least th emid NIneties.

I am seriously considering complaining to my doc of symptoms so I can put it on my insurance and help out someone who needs it. Yep, spent my childhood in Sunday School and am seriously considered criminal conduct to help someone who needs a medication.

Wonder how my Sunday School teacher would handle that one?

Thanks for the moral dilemma, PHRMA. Go, USA!

[LibertyLover]

18. I hope this works -

I take a prophylactic dose of tetracycline to help control my rosecea. I know rosecea isn't cancer or anything that is going to kill me, but it's still nice not to have a red, blotchy, nasty-looking face. Anyway, I went to renew my script and got a call from the pharmacy. They don't have it in stock and they don't know when they are going to have it in stock again. I'm fine in terms of my rosecea treatment, but tetracycline happens to be one of the only antibiotics that I'm not allergic to, so now I'm hoping that I don't wind up needing it on a non-prophylactic basis for an infection.