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Prescription Drug Shortages Here In The USA--Are You Kidding Me?

Posted on behalf of Goldberg Finnegan, LLC on Jul 25, 2011 in Drug Litigation

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A friend of mine is currently undergoing chemotherapy treatment for cancer. He is an incredible person, strong as an ox physically, and I am 100% confident he will pull through. He also has some of the very best doctors treating him. My friend is a Montgomery County, Maryland School teacher and also is the coach of the Scotland Stars Basketball Team that Goldberg Finnegan sponsors

I was shocked to learn that despite his doctors' best efforts, they will not be able to get his final dose of Bleomycin (chemotherapy agent) because there is a nationwide shortage of this drug. You see, the drug is no longer on patent and it is now manufactured by a generic drug maker - I believe Teva Pharmaceuticals. Drug companies may choose not to continue to manufacture certain prescription drugs that have a relatively low profit margin, and instead focus their manufacturing resources on drugs that have a higher profit margin. This is another example of how greed and money are what drives the decision making process within the pharmaceutical industry.

I have been thinking about whether drug companies that stop making a drug that saves lives and that people need are legally obligated to continue to produce the drug. Honestly, I don't think pharmaceutical companies necessarily have a legal duty to continue to manufacture a lifesaving drug if they don't want to. In other words, I do not think that a consumer who wants a lifesaving cancer curing chemotherapy drug can sue the manufacturer under general negligence and/or product liability laws because the manufacturer does not necessarily have a direct duty to consumers in general. That said, the pharmaceutical companies may have a legal duty to inform consumers and doctors of upcoming foreseeable drug shortages-especially to patients who already have started therapy with a particular drug. The pharmaceutical industry certainly has a moral and ethical obligation to continue to produce life saving drugs, even if it does not make "Big Pharma" money in the short term. It is simply the right thing to do.

Unfortunately, big pharmaceutical companies don't have a heart. Moral and ethical duties do not resonate with most corporations. Since there does not seem to be a legal duty for the drug companies to do the right thing, we need legislation to protect patients such as my friend. This is an area where our government, the FDA, and perhaps state regulatory agencies should step in. These regulatory agencies should be able to issue orders requiring the continued manufacture of much needed cancer curing drugs. Also, the FDA should require drug companies to issue notices to the medical and patient community of upcoming shortages and be forced to state the reason for the shortage.

Prescription drug shortages are a serious problem and it does not only affect cancer drugs. Drug shortages also occur with antibiotics, heart medication, blood pressure medication (Dyazide and Maxide) and even ADHD drugs such as Adderall. In 2010 there were 211 reported shortages. So far in 2011 there have already been about 196 known shortages. This is not a good trend. Currently, the Food and Drug Administration does not have the legal authority to require drug companies to report shortages or reasons for shortages. There is some information available on the FDA Website Drug Shortages FDA.pdf- but the Website clearly states:

"The information provided in this section is provided voluntarily by manufacturers. FDA cannot require firms to report the reason for shortage or duration of the shortage or any other information about shortages."

Without accurate information from the pharmaceutical industry about why there are shortages and when these shortages will occur, it is impossible for doctors and patients suffering from cancer to make appropriate medical decisions. Patients and doctors are encouraged to report known drug shortages by email at drugshortages@fda.hhs.gov

I was shocked to learn that drug shortages could occur with life saving drugs such as Bleomycin. The good news is that there is currently legislation making its way through Congress that may solve the problem. The text of the Preserving Access to Life-Saving Medications Act of 2011 (H.R. 2245) can be found here.HR 2245 Preserving Access.pdf The proposed law requires drug manufacturers to report planned discontinuances of at least 6 months in advance of the discontinuance or as soon as they become aware of the discontinuance. If drug manufacturers knowingly fails to provide this information they are subject to a fine of $10,000.00 per day up to $1,800,000.00. The law also requires the GAO to conduct a study to analyze the law's impact on the FDA ability to prevent prescription drug shortages. The law does contain a few loopholes that allow for drug companies to reduce the 6 month notice period

My analysis of this proposed law is that it is a good first step in the right direction, but it does not quite go far enough. Most likely the law was watered down by lobbyists for the pharmaceutical industry. Ideally the law should require the drug company to certify the reason for the shortage and/or discontinuance of the drug. The law does not seem to require such information but ironically, it requires that the FDA examine the causes of drug shortages. Wouldn't it make sense to have the manufacturers provide the FDA with the critical information needed to conduct this study/examination???

I am also concerned that the proposed legislation gives too much Rule Making Authority to the Secretary of Health and Human Services-thus allowing lobbyists for the drug companies to continue to weigh in on how the law is implemented and enforced. Hopefully, as soon as Congress resolves the debt crisis the Preserving Access to Life-Saving Medications Act of 2011 will be passed with an added provision that requires the reason for the shortages. In the meantime, we recommend that consumers do the following:

1. Call your U.S. Representatives and Senators and urge them to pass the Preserving Access to Life-Saving Medications Act of 2011.

2. If you have prescription medications, don't wait until you are totally out to refill the prescription. Get an earlier refill so that if you run into an issue with the drug being out of production you have time to speak to your doctor about a reasonable alternative.

3. Consider asking your pharmacist if they are aware of any problems getting adequate supplies of the prescription drugs you rely on.

4. If you are diagnosed with cancer, be sure to ask your doctor about whether supply issues may impact the proposed treatment plan. Do your own research on the Internet and the FDA Website. Ask questions!

Kevin I. Goldberg
Goldberg Finnegan, LLC
(888) 213-8140 x102

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