Skip to comments.Another order is signed
Posted on 10/31/2011 1:26:18 PM PDT by ColdOne
President Obama signed his latest executive order this afternoon, saying of the initiative to address a drug shortage that "we've got to go ahead and move forward."
He concluded, somewhat awkwardly: "All right. With that, I'm going to sign this bill -- or this executive order -- excuse
(Excerpt) Read more at politico.com ...
drug shortage. First I’ve heard of it. Glad it’s all handled now, though. /s
Heritage,CAGW,NTU or some other think tank should add up the cost of all those EOs to implement.
There has been a reported drug shortage. I’ve read about it a few times. Not sure which drugs - I think in particular it is some of the more expensive drugs, because the pharmacies, suppliers and hospitals don’t want to tie up cash in inventory. But I could be wrong about the reason - or even if the shortage is true. I just know I’ve read about it a few times.
Woo hoo! He defunded The FDA???
I didn’t know there was a drug shortage.
Even so, I predict the shortage was caused by government meddling, subsidies or regulation (or all three) but will be blamed on evil corporations and/or white people.
Nothing to see here. Crisis averted. Move on.
Barry has a lot to go to catch up to the left’s hero, FDR.
(He issued 3,400 EOs. )
To catch up now would require foregoing some golfing.
The Republic is dead. Long live the King!
(OMG do I really need a sarc tag for this?)
Also, the 1 mm + stolen prescription forms recently reported might be artificially affecting the demand situation. Glad more supply is going to handle that.
Is it sarcasm if its true?
He concluded, somewhat awkwardly: “All right. With that, I’m going to sign this bill — or this executive order — excuse
Therein lies the problem. Sarcastic and factual at the same time.
Thank you, I have my moments.
I think they are sitting around awaiting their next vacation.
What a feckless, balless group of pantywaists.
Here 'tiz ...
The White House
Office of the Press Secretary
For Immediate Release October 31, 2011 Executive Order -- Reducing Prescription Drug Shortages
REDUCING PRESCRIPTION DRUG SHORTAGES By the authority vested in me as President by the Constitution and the laws of the United States of America, it is hereby ordered as follows:
Section 1. Policy. Shortages of pharmaceutical drugs pose a serious and growing threat to public health. While a very small number of drugs in the United States experience a shortage in any given year, the number of prescription drug shortages in the United States nearly tripled between 2005 and 2010, and shortages are becoming more severe as well as more frequent. The affected medicines include cancer treatments, anesthesia drugs, and other drugs that are critical to the treatment and prevention of serious diseases and life threatening conditions.
For example, over approximately the last 5 years, data indicates that the use of sterile injectable cancer treatments has increased by about 20 percent, without a corresponding increase in production capacity. While manufacturers are currently in the process of expanding capacity, it may be several years before production capacity has been significantly increased. Interruptions in the supplies of these drugs endanger patient safety and burden doctors, hospitals, pharmacists, and patients. They also increase health care costs, particularly because some participants in the market may use shortages as opportunities to hoard scarce drugs or charge exorbitant prices.
The Food and Drug Administration (FDA) in the Department of Health and Human Services has been working diligently to address this problem through its existing regulatory framework. While the root problems and many of their solutions are outside of the FDA's control, the agency has worked cooperatively with manufacturers to prevent or mitigate shortages by expediting review of certain regulatory submissions and adopting a flexible approach to drug manufacturing and importation regulations where appropriate. As a result, the FDA prevented 137 drug shortages in 2010 and 2011. Despite these successes, however, the problem of drug shortages has continued to grow.
Many different factors contribute to drug shortages, and solving this critical public health problem will require a multifaceted approach. An important factor in many of the recent shortages appears to be an increase in demand that exceeds current manufacturing capacity. While manufacturers are in the process of expanding capacity, one important step is ensuring that the FDA and the public receive adequate advance notice of shortages whenever possible. The FDA cannot begin to work with manufacturers or use the other tools at its disposal until it knows there is a potential problem. Similarly, early disclosure of a shortage can help hospitals, doctors, and patients make alternative arrangements before a shortage becomes a crisis. However, drug manufacturers have not consistently provided the FDA with adequate notice of potential shortages.
As part of my Administration's broader effort to work with manufacturers, health care providers, and other stakeholders to prevent drug shortages, this order directs the FDA to take steps that will help to prevent and reduce current and future disruptions in the supply of lifesaving medicines.
Sec. 2. Broader Reporting of Manufacturing Discontinuances. To the extent permitted by law, the FDA shall use all appropriate administrative tools, including its authority to interpret and administer the reporting requirements in 21 U.S.C. 356c, to require drug manufacturers to provide adequate advance notice of manufacturing discontinuances that could lead to shortages of drugs that are life supporting or life sustaining, or that prevent debilitating disease.
Sec. 3. Expedited Regulatory Review. To the extent practicable, and consistent with its statutory responsibility to ensure the safety and effectiveness of the drug supply, the FDA shall take steps to expand its current efforts to expedite its regulatory reviews, including reviews of new drug suppliers, manufacturing sites, and manufacturing changes, whenever it determines that expedited review would help to avoid or mitigate existing or potential drug shortages. In prioritizing and allocating its limited resources, the FDA should consider both the severity of the shortage and the importance of the affected drug to public health.
Sec. 4. Review of Certain Behaviors by Market Participants. The FDA shall communicate to the Department of Justice (DOJ) any findings that shortages have led market participants to stockpile the affected drugs or sell them at exorbitant prices. The DOJ shall then determine whether these activities are consistent with applicable law. Based on its determination, DOJ, in coordination with other State and Federal regulatory agencies as appropriate, should undertake whatever enforcement actions, if any, it deems appropriate.
Sec. 5. General Provisions. (a) Nothing in this order shall be construed to impair or otherwise affect:
(i) authority granted by law to an agency, or the head thereof; or
(ii) functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals.
(b) This order shall be implemented consistent with applicable law and subject to the availability of appropriations.
(c) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.
THE WHITE HOUSE,
October 31, 2011.
there has been a drug shortage since shortly after OBAMA took office, now when we refill my son’s adhd meds we never know how many pills we will get, if any
not sure which of his “czars” screwed things up
Almost certain his latest despotic decree will make things worse
Well shoot - if’n he can just do an EO to get rid of this drug shortage, why can’t he just do an EO to get rid of the job shortage? I guess he’s too stupid to think of that.
LOL, I doubt the burglars, robbers and counterfeiters are interested in chemotherapies. As I’m sure you know there is a big black market for opiates and anti-anxiety drugs and steroids.
Thank you for posting.
If I were a business owner I would be slowing production due to the sagging economy and the uncertainty that hangs like a cloud over this administration.
there is a major drug shortage, mostly because of new regulations.
I don’t think it is revenue-related. I think it is just the WH and DOJ teaming up to throw their weight around and set themselves up for making rules about how to best ration drugs in the future.
FWIW, I do know there is one that is needed so I can get retested for cancer markers. Waiting for my endo to contact me when it’s available. Can’t tell you what the drug is but I had thyroid cancer if that’s any clue.
Last week, I had an interesting experience at the pharmacy. I get a three-month supply for synthroid, of which I take two a day. Pharmacist hands me the bag with the prescription in there... and by God, it felt light. I took it out of the bag right then and there, looked at it and told her it didn’t look like there were enough in it. Got the “are you kidding?” look but another gal asked if I wanted it recounted. “Yes, please.” I watched her do so and sure enough, it was short 30 pills.
Didn’t Bill or Hillary try something like this and it went sideways?
Which regulations? Just curious and trying to dig up info about this.
I don’t have the list handy but regulations were put in place after BO took office which made it more difficult to produce drugs. Pretty much the same thing he’s been doing to the oil industry.
There have been numerous stories about critical drugs, many of them for cancer, being in short supply. They usually reference manufacturing problems.