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Drug Shortages at All-time High
The following is a summary of drug shortages in the U.S.
2005 - 61
2006 - 56
2007 - 90
2008 - 110
2009 - 157
2010 - 178
2011 - 246+
As is evident, shortages for 2011 are at an all-time high. Several reasons are given for the problem: (1) shortages of raw materials, (2) firms are discontinuing older, and off-patent drugs in favor of newer and more profitable ones, (3) issuing large recalls of drugs due to quality problems identified by the FDA.
A summary report on drug shortages by the American Society of Health-System Pharmacists (ASHP), the American Society of Anesthesiologists (ASA), the American Society of Clinical Oncology (ASCO), and the Institute for Safe Medication Practices (ISMP) states the following.
1. Several drug shortages (e.g., concentrated morphine sulfate solution, levothyroxine injection) have been precipitated by actual or anticipated action by the FDA as part of the Unapproved Drugs Initiative (drugs commonly called pre-1938 drugs, referring to their availability prior to passage of the Food, Drug, and Cosmetic Act of that year.) Some participants noted that the cost and complexity of completing a New Drug Application (NDA) for those unapproved drugs is a disincentive for entering or maintaining a market presence.
2. Other regulatory barriers include the time for FDA review of Abbreviated New Drug Applications (ANDA) and supplemental applications, which are required for changes to FDA-approved drug products (e.g., change in source for active pharmaceutical ingredients API, change in manufacturer). Manufacturers described this approval process as lengthy and unpredictable, which limits their ability to develop reliable production schedules.
3. Manufacturing-related causes that contribute to drug shortages are multifactorial, including the inability to fully comply with GMP, which results in production stoppages or recalls. The FDA has been stepping up its enforcement efforts-levying fines and forcing manufacturers to retool their facilities both here and abroad. Not only has this more rigorous regulatory oversight slowed down production, the FDA's "zero tolerance" regime is forcing manufacturers to abide by rules that are rigid, inflexible, and unforgiving. For example, a drug manufacturer must get approval for how much of a drug it plans to produce, as well as the timeframe. If a shortage develops (because, say, the FDA shuts down a competitor's plant), a drug manufacturer cannot increase its output of that drug without another round of approvals. Nor can it alter its timetable production (producing a shortage drug earlier than planned) without FDA approval.
http://money.cnn.com/2011/06/10/news/economy/drug_shortages_fda/?section=money_latest
http://marginalrevolution.com/marginalrevolution/2011/06/drug-shortages.html
India's Dr Reddy's Mexico Facility Gets US FDA Warning Letter
The FDA has issued a warning letter to the Mexican facility at Cuernavaca, Mexico of Indian drug maker Dr Reddy's Laboratories Ltd for violating manufacturing standards. The agency warned that it might not approve the sale of drugs that list the Dr Reddy's unit as the ingredients manufacturer and might also ban entry of products made at the facility into the U.S. till the issues were resolved to its satisfaction.
Indian generic drugmakers, including rival Ranbaxy, are poised to benefit as drugs worth about $100 billion lose patent protection over the next two years. However, they face intense competition, rising lawsuits from rival firms, and stricter U.S. regulation in their race for the lucrative off-patent market. Many manufacturers have fallen foul of the FDA over standards and processes.
http://www.reuters.com/article/2011/06/14/drreddys-warning-idUSL3E7HE2VX20110614
http://www.foxbusiness.com/industries/2011/06/14/dr-reddys-mexico-facility-gets-us-fda-warning-letter/
http://pharmalive.com/news/index.cfm?articleID=788168&categoryid=9&newsletter=1#
Researchers Question Safety of Mist Inhalers for Delivering Common Drug for Chronic Lung Disease
The British Medical Journal reports that patients who use a mist inhaler to deliver a drug widely prescribed in more than 55 countries to treat chronic obstructive pulmonary disease (COPD) may be 52 percent more likely to die, new Johns Hopkins-led research suggests. The mist inhaler delivers the soluble form of tiotropium. The mist inhaler has not yet gained regulatory approval in the U.S., but the drug in its powdered form is commonly used to treat COPD here.
Thoughts are that the problem is that the mist inhaler is delivering a higher concentration of tiotropium than it should be and that may be increasing the risk of death. The increased deaths linked to the inhaler are primarily from cardiovascular disease.
http://pharmalive.com/news/index.cfm?articleID=788197&categoryid=9&newsletter=1
Glaxo Tax Disputes Could Cost Philadelphia Area School Districts Millions
In what may be the largest property-tax dispute in the region, two of Montgomery County's school districts stand to lose millions of dollars a year in tax payments from the pharmaceutical giant GlaxoSmithKline. They anticipate that between $2 million and $3.5 million a year in Glaxo tax payments will disappear when the cases are concluded.
The districts explain that the large amounts involved are contributing factors in cutbacks and higher taxes they are planning for next school year. Many school districts have seen a flurry of successful challenges whittle away at the amount of money they receive in taxes as businesses and homeowners ask county assessors and the courts to adjust property assessments lower in light of the changing real estate market.
http://pharmalive.com/news/index.cfm?articleID=788204&categoryid=9&newsletter=1
Merck Revises Drug Labels to Cut Dispensing Errors
Merck will soon be shipping many of its top medications to pharmacies in containers with labels redesigned to prevent dispensing errors. The revised labels will go on 16 different oral medications, including Januvia, Janumet, Singulair, Propecia, and Isentress.
The label changes include increasing the font size of the drug's brand and chemical names, adding a 3-D picture of the medicine tablet, moving the drug's expiration date and special coding needed by the pharmacist to more prominent positions, and putting two color-coded bands on the bottles, one for the brand and a second one for the dosage strength.
http://www.pharmacistelink.com/index.php/drugs-and-treatment/30466
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