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Editorial: Drug Shortages 2013

What is the status of the drug-shortage problem today? We hear and even read that the complex issue of drug shortages is a high priority for the FDA. The FDA Safety and Innovation Act of 2012 (FDASIA) intent was to provide the tools the agency needed to prevent or resolve a shortage, and details long-term solutions to address the underlying causes. FDASIA also emphasizes opportunities for pharmaceutical manufacturers to prevent drug shortages by promoting and sustaining quality manufacturing. A proposed rule has just now been issued requiring all manufacturers of certain medically important prescription drugs to give FDA at least 6-month notice in advance, if practical. Despite announcements praising the FDA's efforts to minimize the shortages, let's look at the numbers.

In 2012, the number of "new" shortages dropped to 117 from 251 in 2011. According to reports, although the number of "new" shortages dropped in 2012, the number for on-going shortages was more than 300 at the end of that year. Also, from 2010 to 2012, the U.S. experienced 546 drug shortages, with 399 of them involving sterile, injectable drugs. According to the FDA, most of these shortages were caused by quality and manufacturing issues while others were caused by a lack of raw materials and components from suppliers.

It is quite evident that something is not working. The FDA claims that it helped to prevent 195 drug shortages in 2011 and 282 drug shortages in 2012, and that is commendable. However, there are many factors involved in drug shortages. Meanwhile, with over 240 drug shortages right now, physician's choices become limited and compounding pharmacists are the primary mechanism for seeing us through these times.


Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition

For text of bill, go to: https://www.govtrack.us/congress/bills/113/hr3204/text

Generic Drug Manufacturer Faked Test Results for FDA Approval
About 80% of the drugs prescribed today are generic drugs, many of which are made in India. A leading manufacturer, Ranbaxy, often skipped the required steps for approval of its generic drugs. In 2008, Ranbaxy was prohibited by the FDA from shipping drugs to the U.S. from two Indian plants; however, the company continued to sell drugs in the U.S. from its other Indian facilities. In 2011, while the FDA was investigating Ranbaxy for serious criminal violations, the FDA was approving the company for the exclusive rights to make the generic version of one of the most popular pharmaceuticals of all time: Lipitor. This reportedly earned the company $600 million in the first six months. The federal investigation led Ranbaxy to plead guilty to seven felonies; Ranbaxy was bought by the Japanese firm Daiichi Sankyo in 2008.
http://www.cbsnews.com/8301-18563_162-57610994/leading-generic-drug-maker-faked-test-results-for-fda-approval/

FDA to Withdraw Approval of 14 Drugs
The FDA has begun the process of withdrawing approval for 14 drugs because the manufacturers "have repeatedly failed to file required annual reports for these applications." The manufacturers of the products in question include USV Pharmaceutical Corp., Dow Pharmaceutical Corp., and Nordic Biochemicals. The companies can contest the FDA decision but must request a hearing in writing by December 5. If no request is made, the FDA will withdraw approval of the drugs.
http://www.modernhealthcare.com/article/20131105/BLOG/311059998/fda-takes-steps-to-withdraw-approval-for-14-drugs

FDA Concerned About Pharmacy Compounding Bill
The Drug Quality and Security Act doesn't go all the way according to Commissioner Margaret Hamburg. She said it's not that the FDA is looking for a lot of new responsibilities, but when there is a health and safety problem where we think that we have the expertise and where clearly there should be national standards, we do believe that we should be given the authority that is needed.
http://thehill.com/blogs/regwatch/legislation/189300-fda-not-sold-on-pharmacy-compounding-bill

Kickbacks Okay to Pharmaceutical Companies on Health Exchanges
The DHHS has announced that it won't hold the new insurance offerings available on state and federally run exchanges to the same anti-kickback standards maintained for federal health programs such as Medicare. The anti-kickback rules have been in effect since 1991 and generally prohibit companies from making payments to beneficiaries or other firms to induce business paid for by Medicare and other federal programs. These activities can range from paying rebates to Medicare beneficiaries for buying specific drugs to paying physicians to refer their patients to a specific imaging facility.
http://blogs.wsj.com/corporate-intelligence/2013/11/01/kickbacks-from-drug-makers-given-all-clear-on-health-exchanges/

Drug-shortage Help Requested by the FDA
The FDA announced a new proposal to try and head off more shortages of crucial medications that have disrupted care at hospitals and clinics nationwide. This proposed rule addressing companies that make medically important prescription medicines would have to notify the FDA six months ahead of any changes that could disrupt the U.S. supply. This includes plans to discontinue a product or manufacturing changes that could slow production. The agency cannot require companies to increase manufacturing capacity to guard against shortages, or to require a company to make a product if it is not profitable.
http://hosted.ap.org/dynamic/stories/U/US_DRUG_SHORTAGES_FDA?SITE=AP&SECTION=HOME&TEMPLATE=DEFAULT
http://www.reuters.com/article/2013/10/31/us-drug-shortages-idUSBRE99U0XG20131031

18 Lots of Acetaminophen Infant Suspension Recalled
Perrigo Company has announced it has initiated a voluntary, nationwide product recall to the retail level of 18 batches of its acetaminophen infant suspension liquid, 160 mg/5 mL, sold in boxed packages of 2-oz. and 4-oz. bottles with syringes. The recall is being initiated because a small number of packages might contain an oral dosing syringe without dose markings. Using an oral syringe without dose markings could result in inaccurate dosing, especially in infants who could mistakenly get too high a dose.
http://www.fiercepharma.com/press-releases/perrigo-initiates-nationwide-voluntary-product-recall-acetaminophen-infant-0?utm_medium=nl&utm_source=internal

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