Pharmaceutical News

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November 30, 2009
Court Rules Generic Drug Makers Must Provide Adequate Labeling
A three-judge panel of the U.S. Court of Appeals for the Eight Circuit has ruled that generic drug manufacturers must provide adequate warnings on the labels of their medication.  The significant ruling is the first federal preemption case of this kind to be decided on the appellate level. The ruling reverses an earlier decision by the U.S. District Court for the District of Minnesota. While finding the generic drug makers responsible, the appellate court also found that the plaintiff had no claim against brand-name manufacturers since she had not ingested any of their medication.

The plaintiff originally sued Wyeth Inc., and others after developing a disabling neurological disorder called tardive dyskinesia four years after taking a generic form of the drug Reglan (metoclopramide). According to the plaintiff’s complaint, the risk of tardive dyskinesia was not clearly indicated on the label. The complaint also alleged that the drug was promoted for long-term use, although the FDA only approved it for short-term use since the risk of tardive dyskinesia grows significantly with use longer than 12 weeks. According to court documents, 70 percent of metoclopramide prescriptions are now filled by generics.
Law 360

September 25, 2009
Study Finds SSRI’s Taken Early in Pregnancy Double Risk of Birth Defect
Researchers from Denmark’s Aarhus University were surprised to find that taking certain antidepressants in the early stages of a pregnancy may lead to double, and in some cases triple, the risk of certain birth defects.  The study, published in the September 25th Online First issue of BMJ, tied the use of selective serotonin reuptake inhibitors (SSRI) such as Prozac and Zoloft with a heart defect involving a piece of tissue that separates parts of the heart.  According to the study, taking Prozac doubled the risk of this defect, taking Zoloft more than tripled it and taking more than one SSRI pushed the risk of having a baby with this particular heart defect to nearly five times more likely.

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August 19, 2009
New Study Finds Avandia More Dangerous Than Counterpart
A new study published in the British Medical Journal has led Canadian scientists to conclude that continued use of the diabetes drug Avandia may not be justified.  In the latest blow to GlaxoSmithKline’s blockbuster drug, new findings show that diabetics who take Avandia are more likely to suffer heart failure or death than those taking its counterpart, Takeda Pharmaceutical’s Actos.  Both Avandia and Actos are used to treat patients suffering from type 2 diabetes and both medications pose a risk of fluid retention and heart failure in some patients.  According to the new research, however, Actos may be a much safer alternative.  According to the findings, for every 120 diabetics taking Avandia instead of Actos, one additional hospitalization due to heart failure would occur and for every 269 patients taking Avandia instead of Actos, there would be one additional death.

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August 18, 2009
FDA to Determine BPA safety by Nov. 30, Based on Pending Review of New Research
The Food and Drug Administration announced that it will determine by Nov. 30 whether bisphenol A is safe for use in food and beverage containers.  The FDA announced their timeline on Aug. 17, stating that the decision will be based on a pending review of new studies on the controversial chemical.  Many environmental activists have criticized the timeline, accusing the FDA of delaying the decision.  Numerous recent studies have linked the chemical to heart disease, diabetes and breast cancer.  The new FDA analysis will include more than 100 new studies, including those that included low doses of BPA.

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July 30, 2009
House Passes Food Safety Bill Requiring FDA Assessment of BPA
On July 30, 2009, the House of Representatives passed a food safety bill that would potentially compel the FDA to make a determination about the safety of the controversial chemical Bisphenol A.  If passed, Section 215 of the Food Safety and Enhancement Act of 2009 will require the FDA to inform Congress whether there is reasonable certainty of no harm associated with BPA, according to available scientific data.   The FDA will have to decide, by the end of 2009, if the available data supports the conclusion that infants, young children, pregnant women and adults are not in danger when using polycarbonate plastic and epoxy resin containing BPA.  The bill would further require the agency to propose restrictions on the chemical if the determination is not made.  The Senate does not currently have a companion bill

May 11, 2009
FDA:  A-S Medications Solutions LLC Announces Nationwide Digoxin Recall
On May 11, 2009, A-S Medications Solution LLC announced a nationwide recall of all lots of digoxin tablets 0.25mg due to size variability.  The voluntary recall pertains to Caraco brand Digoxin tablets, USP, 0.25 mg, that were distributed before March 31, 2009, which are not expired and are within the expiration date of August, 2011.  The recalled tablets may differ in size, having more or less of the active ingredient, digoxin.  Excessive digoxin intake can lead to digoxin toxicity, which can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability, slow heart rate and even death.  Also, a lower than labeled digoxin dose can lead to heart failure or abnormal heart rhythms, the very two ailments that digoxin is meant to treat.

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April 29, 2009
Proposed Bill Seeks More FDA Oversight of Foreign Medical Cos.
Sens. Chuck Grassley, R-Iowa, and Edward Kennedy, D-Mass., have proposed a bill that would give the FDA more authority in their scrutiny of foreign medical device and drug manufacturers.  The bill, called the Drug and Device Accountability Act of 2009, was presented on April 23.  It will potentially allow the FDA to hold foreign drug Class II and Class III device manufacturers accountable for unsafe manufacturing practices.  It would also require these companies to receive FDA certification and submit to more frequent inspections.  The bill comes after recent “troubling findings” regarding the agency’s handling of foreign drug companies.

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April 27, 2009
FDA Sends Warning Letters to Chinese Suppliers of Heparin
The FDA has cited two Chinese suppliers of the blood thinner, heparin, for failing to follow safe drug manufacturing practices.  In warning letters sent to Shanghai No. 1 Biochemical & Pharmaceutical and manufacturer Qingdao Jiulong Biopharmaceuticals, the FDA continued its probe into contaminated Chinese-made heparin, which last year was linked to 80 deaths in the U.S. The letters reinforce the FDA’s investigation into the companies’ involvement with the manufacture and marketing of the faulty heparin.

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March 31, 2009
Caraco Pharmaceutical Laboratories, Ltd. Voluntarily
Recalls All Lots of Digoxin Tablets Due to Variability in Pill Size
Generic pharmaceutical company Caraco Pharmaceutical Laboratories, Ltd. has voluntarily recalled all tablets of Caraco brand Digoxin, USP, 0.125 mg, and Digoxin, USP, 0.25 mg, distributed prior to March 31, 2009, which are not expired and are within the expiration date of September, 2011.  According to the company’s press release, the recalled tablets may differ in size and could have the wrong amount of the active ingredient, digoxin, a drug product used to treat heart failure and abnormal heart rhythms.  The recall caused concern since digoxin toxicity, caused by excessive digoxin intake, can cause nausea, low blood pressure, cardiac instability and death.  Consumers are urged to return the recalled product to their pharmacy or place of purchase.

March 10, 2009
U.S. Supreme Court Resuscitates Antidepressant Lawsuits
On March 9 , 2009, the U.S. Supreme Court revived two lawsuits blaming Pfizer Inc. and a GlaxoSmithKline P.L.C. unit for failing to warn that their antidepressants might cause suicidal tendencies in adults.  In light of the previous Supreme Court decision giving patients more ability to sue drug makers, the justices asked the U.S. Court of Appeals for the Third Circuit in Philadelphia to reconsider the suits, which they had previously rejected.  The lawsuits are being pushed by survivors of a woman and a man who killed themselves after taking Glaxo’s Paxil and Pfizer’s Zoloft, respectively.

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February 25, 2009
Manhunt Underway for President of Company Accused
of Shipping Bacteria-Laden Syringes
There is currently an international manhunt for the president of AM2PAT, a company who is accused of knowingly shipping bacteria-laden pre-filled syringes that have led to at least five deaths and sickened hundreds of people.  The former president of Raleigh, N.C.-based AM2PAT, Dushyant Patel, is believed to be hiding out in his native India, although this is not confirmed.  Patel has been charged with fraud and adulterating medical devices.  Two others who worked at AM2PAT, a manager and quality control inspector,  pled guilty and were sentenced to 54 month prison terms.  AM2PAT syringes were pulled from the market in 2007 after reports linked the syringes to infections of the urinary tract and circulatory system.  Sales of AM2PAT pre-filled syringes were at $6.9 million in 2006 and 2007.
Law 360

January 30, 2009
GSK Takes $400M Hit Pending Investigation into "Off-Label" Drug Marketing
GlaxoSmithKline is taking a $400 million legal charge in the fourth quarter because of an investigation into the sales and marketing practices from 1997 to 2004 of nine of its blockbuster drugs, said the company. The Colorado U.S. Attorney's Office are said to be looking into the "off-label" marketing of GSK’s best selling antidepressants Wellbutrin SR and Paxil, amongst others. According to the Wall St. Journal, Glaxo didn’t specify whether it was moving toward a settlement, but said its decision to take the charge “reflects the current status of the investigation, and is based upon the company’s most recent evaluation of the matter.”

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January 30, 2009
Pharmaceutical Giant Eli Lilly Pleads Guilty in Zyprexa Case
Pharmaceutical giant Eli Lilly and Company (LLY, Fortune 500) pleaded guilty Friday to a misdemeanor charge of ‘off-label’ marketing of their anti-psychotic drug Zyprexa. According to federal prosecutors, the company illegally promoted the drug for uses not approved by the Food and Drug Administration. As a part of the plea agreement and civil settlement, Eli Lilly was ordered to pay a total penalty of over $1.4 billion. A portion of the penalty is a fine of $515 million, which is the largest criminal fine ever imposed in a U.S. criminal prosecution for an individual corporation.

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January 28, 2009
Study Finds BPA May Stay in Body Longer than Previously Believed
According to a new government health survey, bisphenol A, or BPA, a controversial chemical used in many plastic products, may remain in the body longer than previously thought. The study, conducted by Dr. Richard Stahlhut of the University of Rochester and colleagues, found that significant BPA levels remained in the body even in people who had fasted for 24 hours. Researchers also believe that people may be ingesting the potentially dangerous chemical from sources other than food, such as tap water or house dust. The precious belief was that BPA quickly and completely exited the body through urine. The FDA has no immediate plans to stop the use of the chemical in products such as baby bottles and food cans.

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January 9, 2009
FDA Awaits Court's Entry of A Permanent Injunction Against Actavis Totowa, LLC
The Food and Drug Administration reached an agreement with Generic-drug maker Actavis Group regarding the company’s Actavis Totowa LLC subsidiary. The Consent Decree requires Actavis to halt production and distribution of products manufactured at its U.S. subsidiary’s New Jersey plant in order to upgrade the facilities to meet the FDA’s manufacturing standards. The consent decree follows a lawsuit filed in November by the U.S. Department of Justice which claimed that a series of regulatory inspections had exposed problems with the company's manufacturing practices. The complaint also sought a permanent injunction to block the company from manufacturing and distributing drugs. Actavis Totowa makes the heart failure drug digoxin (Digitek), which was recalled in April after tablets made double thick and twice as potent were released to the market.

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