Democratic Senators Propose Law to Address Unprecedented Drug Shortages

Democratic Senators Propose Law to Address Unprecedented Drug Shortages The problem of prescription drug shortages reported last month isn't getting any better. Luckily, U.S. legislators are taking note, and Sens. Amy Klobuchar (D-Minn.) and Bob Casey (D-Pa.) introduced a bill Monday to address the unprecedented medication shortfalls. Health care groups applauded the bill "as an important first step."

Pharmacists and health care providers have been reporting unprecedented shortages of prescription drugs, including vital medications such as chemotherapies, antibiotics, analgesics (painkillers), anesthetics and more. Such shortages can compromise therapy or delay treatment, putting patients at risk -- sometimes even of death.

The American Society of Health-System Pharmacists currently lists 150 "medically necessary" drugs that are in short supply, double the number from five years ago, the senators noted

"Reports of drug shortages are unabated," says ASHP Director of Federal Legislative Affairs Joseph Hill. "In addition, recent reports have included drugs critical to care that have not previously been reported."

Similarly, says Dr. Michael Link, president elect of the American Society of Clinical Oncology: "The oncology community is experiencing severe and worsening shortages of many critical drug therapies which disrupt important medication regimens and may threaten patients' health."

Bill Would Empower the FDA to Act


No single reason explains the shortages. Issues include scarcity of raw materials, manufacturing problems, FDA enforcement actions and unexpected increases in demand. Also, business decisions by pharmaceutical manufacturers to cut back on the production of less profitable drugs in favor of more profitable ones can lead to shortages.

Despite the severity of the problem, the Food and Drug Administration has little authority to act. Under current law, it can't even require manufacturers to give it early notification of possible shortages. The senators say their bill, the Preserving Access to Life-Saving Medications Act, which includes several of the recommendations from the drug shortage summit held in November, would provide the FDA with key tools to help address and prevent shortages.

The bill will require manufacturers to give early notification to the FDA of any incidents that would likely result in drug shortages, and would also direct the FDA to provide the public with up-to-date notifications of any shortage situations, and the actions it's taking to address them.

"Physicians, pharmacists and patients are currently among the last to know when an essential drug will no longer be available -- that's not right," said Klobuchar. "This commonsense solution will help set up an early-warning system so pharmacists and physicians can prepare in advance and ensure that patients continue to receive the best care possible."

"Critical First Step"

Early notifications would give doctors, pharmacists and nurses time to find potential substitutes and learn about them so that dispensing errors can be minimized, Michael Cohen, president of the Institute for Safe Medication Practices, explained to DailyFinance last month. Dr. Link of ASCO expresses a similar view, saying the early-notification legislation would help oncologists to better anticipate and manage shortages.

"Drug shortages are hurting patients, and we applaud the Senators' efforts," says the ASHP's Hill. "This bill is a critical first step in addressing drug shortages."

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rondonit

If they've been deemed "Life Saving Drugs" that are not being produced (to keep them off the market), the Federal Government should be able to revoke the patent to allow any qualified manufacturer to bring them to market competetively (make the formula part of the Public Domain). Likewise, if an Oil Company chooses not to pump it's leases at capacity, they should be forced to surrender them back to the USA for redistribution to organizations that will (Lease doesn't entitle the Renter to hoard the supply for the purpose of driving up World Market prices).
Large Corporations would only be harmed if they decided to leverage the marketplace by creating shortages that Small Business would gladly fill.

February 09 2011 at 8:25 PM Report abuse rate up rate down Reply
1 reply to rondonit's comment
bggdg

Doesn't everybody spend billions of dollars on R&D to create drugs, get approval from the FDA, then patent their inventions only to let the result of their invention sit idly collecting dust? How do you think these guys became as successful as they did? By actually creating, producing, and selling products that were in demand in the market? Or pissing shareholders capital down their legs?

February 09 2011 at 11:40 PM Report abuse rate up rate down Reply
Jack

Just another way to raise prices, don't make it, it will grow,,,,,,, like coffee , up 1.58 this past week now $9, when will this end? When Washington is shut down for one. This country is going down the tubes, with communities not talking to each other, cell phones out of control, yeah you must have that call, right, 9/11 did more damage than anyone could imagine.

Well, that is my I scream each day, to let my frustrations out. Government is too big and usless, as the Constitution states, if Government becomes ineffectual then it is the people who should change it. So, let's change it NOW

February 09 2011 at 5:14 PM Report abuse +2 rate up rate down Reply
mlaurel58

During the Bush Administration we were told drug shortages were the fault of one many, and one man only...the man at the top. So following that same logic, how amny of you are prepared to blame the current man at the top?

February 09 2011 at 4:51 PM Report abuse rate up rate down Reply
1 reply to mlaurel58's comment
mlaurel58

sorry for my typos!

February 09 2011 at 4:53 PM Report abuse rate up rate down Reply
howlar2

If a particular drug is not profitable to manufacture, then why should a drug company manufacture it? This is capitalism and they are in business to make a profit and show good return to their share holders. If the government wants these products manufactured then allow the drug manufacturers a fair profit. Quit over-regulating the industry.

February 09 2011 at 4:00 PM Report abuse -1 rate up rate down Reply
thedealdepot

Its the FDA that is already empowered that is holding up production give me a break i work in the industry so the politicians are going to fix the problem they are causing sound sfamiliar whatever! Its the FDA or your government that is responsible for cance patients not getting the meds imagine now that the governemnt controls all health care really? They cant even deliver paper (Mail) without wasting billions!

February 09 2011 at 3:26 PM Report abuse +1 rate up rate down Reply
suitman36

to me, the whole pharmaceutical business is simply a money making machine in some ways.
i spoke to my pharmacist about a drug i was put on. it was a relatively new drug, meaning that now there is no generic equivalent. he said that all a drug company has to do is to change one molecule of the drug, and it can be called a 'new drug' that can't be done generically for 7 years. its really the same old drug with only a minor difference that makes virtually no difference in its effect.

February 09 2011 at 3:17 PM Report abuse +2 rate up rate down Reply
suitman36

man, oh man. even the drug companies have learned that if you create a 'shortage' it will mean a rise in profits.
lets just keep these companies going along with very little regulations. then they are simply free to screw whoever they want while increasing their profits.
truly disgusting!!

February 09 2011 at 3:12 PM Report abuse +2 rate up rate down Reply
1 reply to suitman36's comment
bggdg

I can't believe how quick you were able to discern that the less a business sells of their product, the more they earn. Why didn't drug companies catch on to this basic tenant of economics as easily as did you?

February 09 2011 at 11:46 PM Report abuse rate up rate down Reply
Charles

It's just like everything else we no longer manufacture!! Pretty soon we will not be mmanufacturing anything!!

February 09 2011 at 1:05 PM Report abuse +4 rate up rate down Reply
2 replies to Charles's comment
bggdg

How come only 10% of GDP is imports, and much of those are not manufactured goods (think oil or coffee or bananas, etc.)?

February 09 2011 at 2:51 PM Report abuse rate up rate down Reply
bggdg

While at the same time US manufacturing output is at an all-time high?

February 09 2011 at 2:52 PM Report abuse rate up rate down Reply
leblancaj

OK, a company cuts back on producing a particular drug because the cost of making it is too close to the cost at which they sell it, and therefore their profit is too small. They would rather make something else that is more profitable.

So the government's solution to this is to require the companies to do more work, to set up an "early warning system," which will drive up the total cost of doing business. That makes it likely that additional drugs will now produce profits that are too small, resulting in additional business decisions that will produce additional shortages.

Please get the government out of those decisions! Government actions interfere with supply and demand, CAUSING shortages.

February 09 2011 at 12:29 PM Report abuse -5 rate up rate down Reply
pinus1

Stupid. This rigged shortage was reported on months ago. Now they are going to spend time to pass more laws?
There are already laws on the books against "price-fixing."
This is no more than "supply and demand." Limiting the production and amount to create an artificial shortage.
These elected people also hold an LD. They should know the law and not waste time making new ones. If they want to make some thing new it should be jobs for our hard working middle class.

February 09 2011 at 12:17 PM Report abuse rate up rate down Reply
1 reply to pinus1's comment
bggdg

Because businesses only sell more of the product they are in business to produce and sell when goons force them to do so, right?

February 09 2011 at 2:54 PM Report abuse rate up rate down Reply