Drug & Device News

FDA Warns Against Use of Zicam

The Food and Drug Administration has issued a warning to consumers advising them to stop using the popular over-the-counter cold remedy Zicam because its use has been associated with anosmia, the loss of the sense of smell. The warning covers adult and children's versions of Zicam nasal swabs, as well as Zicam nasal gel. The warning came after the FDA received more than 130 consumer complaints of loss of the sense of smell following Zicam use, sometimes after even one use. The product, which has not been approved by the FDA, has been marketed as a homeopathic remedy. However, FDA has now issued a warning letter to Zicam's manufacturer, Matrixx Initiatives, telling it that it should cease selling the product until such time as it receives FDA approval to market it to the public.

In False Data Case, Doctor's Employment Outside Military Investigated

The army is investigating whether Dr. Timothy R. Kuklo ' a researcher accused of publishing false study results concerning Infuse, a Medtronic Inc. product that promotes bone growth ' violated army policy by taking paid positions in the private sector while still on active military duty. Military personnel are restricted in their ability to take on outside work, and must obtain permission to do so. In this instance, the army suspects that Dr. Kuklo, prior to his 2006 resignation from the army, accepted a teaching position at St. Louis' Washington University and performed part-time work for Medtronic, without first getting approval from his command.

Meanwhile, Sen. Charles Grassley (R-IA), who's been on a campaign to force drug companies and the doctors who work for them to disclose their financial ties, reportedly was able to pressure Medtronic officials to admit that they paid Dr. Kuklo nearly $800,000 for various consulting and other services, beginning in 2001. Meier, The New York Times, 6/24/09.

Feds Say Pharmacists Bilked Health Care Benefits Providers

Pharmacist Pamela Arrey, of Glenelg, MD, was indicted June 18 for health care fraud and aggravated identity theft. She allegedly made claims for reimbursements from medical care benefits programs for refill medications never ordered by her patrons ' medications that were never dispensed. The indictment seeks forfeiture of Arrey's supposed ill-gotten gains, including $350,000 in cash and real estate holdings.

In New Jersey, pharmacist Rueben Aguillar pleaded guilty to a one-count information accusing him of conspiring to commit healthcare fraud by filling prescriptions with generic medications then seeking reimbursement from health care benefits providers for their more expensive name-brand equivalents.

Off-Label Drug- and Device-Use Promotions Brings Criminal Actions

The U.S. Department of Justice has announced the sentence for drug marketer Mary Holloway, who pleaded guilty to charges that she marketed the drug Bextra for uses and doses unapproved by the FDA. She has been assessed a fine of $75,000 and placed on 24-months' probation for encouraging her staff of about 100 drug salespeople to promote the use of Bextra ' a Cox-II inhibitor approved for use in treating arthritis ' for the treatment of acute pain, including pain following surgery. The FDA had previously specifically rejected the drug's manufacturer's request that Bextra be approved for these uses, as tests had not been conducted to show the safety and efficacy of the drug for these purposes. Bextra was withdrawn from the market in 2005 because of the risks of cardiovascular complications with its use.

In a separate matter, medical device maker Norian Corp. and four individuals with the company were indicted in June for promoting their products, Norian XR and Norian SRS, for uses not approved by the FDA. Norian XR is a spine treatment product that has been off the market since 2004. The U.S. Attorney for the Eastern District of Pennsylvania charged Norian, its parent company Synthes and four top Synthes executives with conspiring with others to conduct unauthorized clinical trials on unsuspecting patients. They allegedly promoted the treatment of vertebral compression fractures of the spine with their two products, even though one of those products carried an FDA-approved warning against that specific use.

In addition, the U.S. Attorney's office accuses the device makers of covering up evidence that use of its device might have caused three deaths in patients who were undergoing surgery to relieve spinal problems. According to the indictment, “Norian and Synthes did not recall Norian XR from the market ' which would have required them to disclose details of the three deaths to the FDA ' but instead, compounded their crimes by carrying out a coverup in which they lied to the Fda during and official inspection in May and June 2004.” See Indictment announcement at: http://www.usdoj.gov/usao/pae/News/Pr/2009/jun/synthesrelease.pdf.

In response to the indictment, Synthes Inc. issued a statement: “Synthes has fully cooperated with the government's investigation, which began in 2006, and believes that its marketing practices in connection with 'Norian XR' were proper. The company intends to vigorously defend itself against the charges.” See Synthes release at: http://www.synthes.com/html/News-Details8013.0.html?&tx_synthesnewsbyxml_pi1[showUid]=28.

Drug Quality Problems Prompt Product Seizure

At the request of the FDA, U.S. Marshals on June 25 seized pharmaceutical products manufactured by Caraco Pharmaceutical Laboratories Ltd. (Caraco), at the company's Michigan facilities in Detroit, Farmington Hills, and Wixom. The seizure followed what the FDA termed the company's ongoing failure to use good manufacturing practices, which have allegedly led to manufacturing defects, such as oversized capsules. The seizure may lead to shortages of available choline magnesium trisalicylate oral tablets, which are used as pain relievers, but alternative pain killers are plentiful. Caraco voluntarily recalled its products in January.

FDA Warns Against Use of Zicam

The Food and Drug Administration has issued a warning to consumers advising them to stop using the popular over-the-counter cold remedy Zicam because its use has been associated with anosmia, the loss of the sense of smell. The warning covers adult and children's versions of Zicam nasal swabs, as well as Zicam nasal gel. The warning came after the FDA received more than 130 consumer complaints of loss of the sense of smell following Zicam use, sometimes after even one use. The product, which has not been approved by the FDA, has been marketed as a homeopathic remedy. However, FDA has now issued a warning letter to Zicam's manufacturer, Matrixx Initiatives, telling it that it should cease selling the product until such time as it receives FDA approval to market it to the public.

In False Data Case, Doctor's Employment Outside Military Investigated

The army is investigating whether Dr. Timothy R. Kuklo ' a researcher accused of publishing false study results concerning Infuse, a Medtronic Inc. product that promotes bone growth ' violated army policy by taking paid positions in the private sector while still on active military duty. Military personnel are restricted in their ability to take on outside work, and must obtain permission to do so. In this instance, the army suspects that Dr. Kuklo, prior to his 2006 resignation from the army, accepted a teaching position at St. Louis' Washington University and performed part-time work for Medtronic, without first getting approval from his command.

Meanwhile, Sen. Charles Grassley (R-IA), who's been on a campaign to force drug companies and the doctors who work for them to disclose their financial ties, reportedly was able to pressure Medtronic officials to admit that they paid Dr. Kuklo nearly $800,000 for various consulting and other services, beginning in 2001. Meier, The New York Times, 6/24/09.

Feds Say Pharmacists Bilked Health Care Benefits Providers

Pharmacist Pamela Arrey, of Glenelg, MD, was indicted June 18 for health care fraud and aggravated identity theft. She allegedly made claims for reimbursements from medical care benefits programs for refill medications never ordered by her patrons ' medications that were never dispensed. The indictment seeks forfeiture of Arrey's supposed ill-gotten gains, including $350,000 in cash and real estate holdings.

In New Jersey, pharmacist Rueben Aguillar pleaded guilty to a one-count information accusing him of conspiring to commit healthcare fraud by filling prescriptions with generic medications then seeking reimbursement from health care benefits providers for their more expensive name-brand equivalents.

Off-Label Drug- and Device-Use Promotions Brings Criminal Actions

The U.S. Department of Justice has announced the sentence for drug marketer Mary Holloway, who pleaded guilty to charges that she marketed the drug Bextra for uses and doses unapproved by the FDA. She has been assessed a fine of $75,000 and placed on 24-months' probation for encouraging her staff of about 100 drug salespeople to promote the use of Bextra ' a Cox-II inhibitor approved for use in treating arthritis ' for the treatment of acute pain, including pain following surgery. The FDA had previously specifically rejected the drug's manufacturer's request that Bextra be approved for these uses, as tests had not been conducted to show the safety and efficacy of the drug for these purposes. Bextra was withdrawn from the market in 2005 because of the risks of cardiovascular complications with its use.

In a separate matter, medical device maker Norian Corp. and four individuals with the company were indicted in June for promoting their products, Norian XR and Norian SRS, for uses not approved by the FDA. Norian XR is a spine treatment product that has been off the market since 2004. The U.S. Attorney for the Eastern District of Pennsylvania charged Norian, its parent company Synthes and four top Synthes executives with conspiring with others to conduct unauthorized clinical trials on unsuspecting patients. They allegedly promoted the treatment of vertebral compression fractures of the spine with their two products, even though one of those products carried an FDA-approved warning against that specific use.

In addition, the U.S. Attorney's office accuses the device makers of covering up evidence that use of its device might have caused three deaths in patients who were undergoing surgery to relieve spinal problems. According to the indictment, “Norian and Synthes did not recall Norian XR from the market ' which would have required them to disclose details of the three deaths to the FDA ' but instead, compounded their crimes by carrying out a coverup in which they lied to the Fda during and official inspection in May and June 2004.” See Indictment announcement at: http://www.usdoj.gov/usao/pae/News/Pr/2009/jun/synthesrelease.pdf.

In response to the indictment, Synthes Inc. issued a statement: “Synthes has fully cooperated with the government's investigation, which began in 2006, and believes that its marketing practices in connection with 'Norian XR' were proper. The company intends to vigorously defend itself against the charges.” See Synthes release at: http://www.synthes.com/html/News-Details8013.0.html?&tx_synthesnewsbyxml_pi1[showUid]=28.

Drug Quality Problems Prompt Product Seizure

At the request of the FDA, U.S. Marshals on June 25 seized pharmaceutical products manufactured by Caraco Pharmaceutical Laboratories Ltd. (Caraco), at the company's Michigan facilities in Detroit, Farmington Hills, and Wixom. The seizure followed what the FDA termed the company's ongoing failure to use good manufacturing practices, which have allegedly led to manufacturing defects, such as oversized capsules. The seizure may lead to shortages of available choline magnesium trisalicylate oral tablets, which are used as pain relievers, but alternative pain killers are plentiful. Caraco voluntarily recalled its products in January.