Saturday, November 16, 2013

Proposed FDA Regulation Reopens Courthouse Doors to Consumers After the Mensing Decision

This post from my friend Rick Schulte, from the TrialLawyerCenter.com:



This week the FDA made game changing moves dealing with American health and drug manufacturer liability. Their hope, is that fair game will be established between brand name and generic manufacturers—and that means equal liability.
FDA’s movement for parity stems from the contentious ruling of Pliva v Mensing, 131 2 Ch 2357 (2011).  

The Mensing ruling was a big win for generic drug makers, who make up about 80% of the pharmaceutical market. It states that generic drug manufacturers cannot be sued for failing to warn consumers of dangerous side effects, as long as their labels mirror brand labels. Two years later, the ruling has evolved to be called the “Mensing preemption” because, as a federal law, it overrides state personal injury laws.

In turn, brand name labels are held more severely for liability, while generic labels are essentially granted immunity. A growing post-Mensing trend is that courts will dismiss cases with allegations of design defect, fraud, negligence, and breach or implied or expressed warranty, as essentially failure to warn claims. Ironically, while generic drug makers are actually liable for negligent manufacturing processes and monitoring their mirrored-labels in a timely manner, the over-arching “failure to warn” statute has stonewalled such cases from being heard or ruled fairly. See the cases here.

FDA’s new proposal is to allow generic drug companies to initiate CBE changes (“Changes Being Effected”). This would essentially overrule Mensing, by permitting generic drug companies add or strengthen a warning label without prior FDA approval. The proposal also sates that once approved, drug companies must conform their labels within 30 days (it used to be an ambiguous “as soon as possible”). And finally, both brand and generic labels may use the CBE process to add new warnings to the “Highlights” section of new drug labels (which was previously restricted). With such changes, generic and brand name companies will have no excuse for inappropriate labeling or have immunity from harm caused to American consumers.

The proposed action is a positive step toward protecting the checks and balances of the civil justice system and the pharmaceutical market. Above all, it is a prospective change on behalf of the rights and wellbeing of American consumers.

Stay tuned for news on the official ruling in weeks to come.

This week the FDA made game changing moves dealing with American health and drug manufacturer liability. Their hope, is that fair game will be established between brand name and generic manufacturers—and that means equal liability.
FDA’s movement for parity stems from the contentious ruling of Pliva v Mensing, 131 2 Ch 2357 (2011). The Mensing ruling was a big win for generic drug makers, who make up about 80% of the pharmaceutical market. It states that generic drug manufacturers cannot be sued for failing to warn consumers of dangerous side effects, as long as their labels mirror brand labels. Two years later, the ruling has evolved to be called the “Mensing preemption” because, as a federal law, it overrides state personal injury laws.
In turn, brand name labels are held more severely for liability, while generic labels are essentially granted immunity. A growing post-Mensing trend is that courts will dismiss cases with allegations of design defect, fraud, negligence, and breach or implied or expressed warranty, as essentially failure to warn claims. Ironically, while generic drug makers are actually liable for negligent manufacturing processes and monitoring their mirrored-labels in a timely manner, the over-arching “failure to warn” statute has stonewalled such cases from being heard or ruled fairly. See the cases here.
FDA’s new proposal is to allow generic drug companies to initiate CBE changes (“Changes Being Effected”). This would essentially overrule Mensing, by permitting generic drug companies add or strengthen a warning label without prior FDA approval. The proposal also sates that once approved, drug companies must conform their labels within 30 days (it used to be an ambiguous “as soon as possible”). And finally, both brand and generic labels may use the CBE process to add new warnings to the “Highlights” section of new drug labels (which was previously restricted). With such changes, generic and brand name companies will have no excuse for inappropriate labeling or have immunity from harm caused to American consumers.
The proposed action is a positive step toward protecting the checks and balances of the civil justice system and the pharmaceutical market. Above all, it is a prospective change on behalf of the rights and wellbeing of American consumers.
Stay tuned for news on the official ruling in weeks to come.
- See more at: http://triallawyercenter.com/2013/11/15/proposed-fda-regulation-will-give-consumers-rights-back-after-the-mensing-decision/#sthash.6INlQYqW.dpuf
This week the FDA made game changing moves dealing with American health and drug manufacturer liability. Their hope, is that fair game will be established between brand name and generic manufacturers—and that means equal liability.
FDA’s movement for parity stems from the contentious ruling of Pliva v Mensing, 131 2 Ch 2357 (2011). The Mensing ruling was a big win for generic drug makers, who make up about 80% of the pharmaceutical market. It states that generic drug manufacturers cannot be sued for failing to warn consumers of dangerous side effects, as long as their labels mirror brand labels. Two years later, the ruling has evolved to be called the “Mensing preemption” because, as a federal law, it overrides state personal injury laws.
In turn, brand name labels are held more severely for liability, while generic labels are essentially granted immunity. A growing post-Mensing trend is that courts will dismiss cases with allegations of design defect, fraud, negligence, and breach or implied or expressed warranty, as essentially failure to warn claims. Ironically, while generic drug makers are actually liable for negligent manufacturing processes and monitoring their mirrored-labels in a timely manner, the over-arching “failure to warn” statute has stonewalled such cases from being heard or ruled fairly. See the cases here.
FDA’s new proposal is to allow generic drug companies to initiate CBE changes (“Changes Being Effected”). This would essentially overrule Mensing, by permitting generic drug companies add or strengthen a warning label without prior FDA approval. The proposal also sates that once approved, drug companies must conform their labels within 30 days (it used to be an ambiguous “as soon as possible”). And finally, both brand and generic labels may use the CBE process to add new warnings to the “Highlights” section of new drug labels (which was previously restricted). With such changes, generic and brand name companies will have no excuse for inappropriate labeling or have immunity from harm caused to American consumers.
The proposed action is a positive step toward protecting the checks and balances of the civil justice system and the pharmaceutical market. Above all, it is a prospective change on behalf of the rights and wellbeing of American consumers.
Stay tuned for news on the official ruling in weeks to come.
- See more at: http://triallawyercenter.com/2013/11/15/proposed-fda-regulation-will-give-consumers-rights-back-after-the-mensing-decision/#sthash.6INlQYqW.dpuf

Sunday, November 10, 2013

USPlabs LLC recalls OxyElite Pro dietary supplements; products linked to liver illnesses


From the FDA this weekend:

The U.S. Food and Drug Administration announced today that USPlabs LLC, of Dallas, Texas, is recalling certain OxyElite Pro dietary supplement products that the company markets. The company took this action after receiving a letter from the FDA stating that the products have been linked to liver illnesses and that there is a reasonable probability that the products are adulterated. 

The letter also notified USPlabs that if the company did not initiate a voluntary recall, the FDA could by law order the company to immediately stop distributing the dietary supplements and immediately notify other parties to stop distributing the dietary supplements. The action marks the second time the FDA has exercised its recall authority under the FDA Food Safety Modernization Act (FSMA) by sending such a letter.

“We took this step to ensure that adulterated and harmful products do not reach the American public,” said Deputy Commissioner for Foods and Veterinary Medicine Michael R. Taylor. “We will continue to work with our state, industry and regulatory partners to prevent such products from reaching the public.”

The products involved in the recall include:
  • OxyElite Pro Super Thermo capsules
    --two count capsules UPC #094922417275
    --10 count capsules UPC #094922417251
    --10 count capsules UPC #094922417268
    --21 count capsules UPC #094922426604
    --90 count capsules UPC #094922395573
    --90 count capsules “Pink label” UPC #094922447906
    --180 count capsules UPC #094922447852
     
  • OxyElite Pro Ultra-Intense Thermo capsules
    --three count capsules UPC #094922447883
    --three count capsules UPC #094922447876
    --90 count capsules UPC #094922395627
    --180 count capsules UPC #094922447869
     
  • OxyElite Pro Super Thermo Powder
    --Fruit Punch 0.15 oz UPC #094922417237
    --Fruit Punch 0.15 oz UPC #094922447517
    --Fruit Punch 4.6 oz UPC #094922426369
    --Fruit Punch 5 oz. UPC #094922447487
    --Blue Raspberry 4.6 oz UPC #094922426376
    --Grape Bubblegum 4.6 oz UPC #094922447500
    --Green Apple 4.6 oz. UPC #094922426499

By letter dated Nov. 6, 2013, the FDA notified USPlabs about findings indicating a link between the use of the above listed OxyElite Pro products and a number of liver illnesses reported in Hawaii. The FDA also noted that cases of liver damage after use of these OxyElite Pro products had been found in a number of other states.

In a review of 46 medical records submitted to the FDA by the Hawaii Department of Health, the records indicated that 27 patients, or 58 percent, had taken a dietary supplement labeled as OxyElite Pro prior to becoming ill. Seventeen of the 27 patients (or 63 percent) reported that OxyElite Pro was the only dietary supplement they were taking. One death has occurred among these patients, another patient has required a liver transplant, and others await liver transplants.

In a warning letter issued to USPlabs LLC on Oct. 11, 2013, the FDA informed the company that OxyElite Pro and another dietary supplement called VERSA-1 were deemed to be adulterated. The products contained aegeline, a new dietary ingredient (i.e., an ingredient not marketed in the United States before Oct. 15, 1994) that lacks a history of use or other evidence of safety. The letter stated that failure to immediately cease distribution of all dietary supplements containing aegeline may result in enforcement action.

In addition to the products being recalled, the FDA continues to advise consumers not to use any dietary supplements labeled OxyElite Pro or VERSA-1.

Consumers who believe they have been harmed by using a dietary supplement should contact their health care practitioner.

If consumers think they have suffered a serious harmful effect or illness from a dietary supplement, their health care provider can submit a report by calling the FDA’s MedWatch hotline at 1-800-FDA-1088 or by reporting it online. The MedWatch program allows health care providers to report problems possibly caused by FDA-regulated products such as drugs, medical devices, medical foods and dietary supplements. The identity of the patient is kept confidential.

Consumers can contact USPlabs at 1(800) 890-3067 (Monday-Friday, 9 a.m. - 5 p.m. EST) or info@usplabsdirect.com.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Saturday, November 09, 2013

OxyElite Pro and a CDC update

An interesting read from the CDC:

Notes from the Field: Acute Hepatitis and Liver Failure Following the Use of a Dietary Supplement Intended for Weight Loss or Muscle Building — May–October 2013

On September 9, 2013, the Hawaii Department of Health (HDOH) was notified of seven patients with severe acute hepatitis and fulminant liver failure of unknown etiology. Patients were previously healthy and sought medical care during May-September 2013. Clinicians reported that the seven patients had all used OxyELITE Pro, a dietary supplement marketed for weight loss and muscle gain, before illness onset.

The HDOH, with the CDC and the Food and Drug Administration (FDA), initiated a public health investigation including patient interviews, medical chart reviews, and collection of supplement samples for analysis. Subsequently, a case was defined as acute hepatitis of unknown etiology occurring on or after April 1, 2013 in a person who had consumed a weight loss or muscle-building dietary supplement within the previous 60 days and had a serum alanine aminotransferase level greater than or equal to four times the upper limit of normal (>160 IU/L) and a total bilirubin level greater than or equal to two times the upper limit of normal (>2.5 mg/dL) and a negative evaluation for infections including viral hepatitis. Excluded were other etiologies such as pre-existing autoimmune hepatitis, chronic alcohol use, and chronic liver diseases such as primary biliary cirrhosis, primary sclerosing cholangitis, Wilson's disease, and hemochromatosis.

Clinicians reported 45 possible cases to the Hawaii DOH in response to a public health alert. Of those, 29 have been identified as cases. The patients have a median age of 33 years (range: 16–66); 14 (48%) were male. The date of first reported laboratory test was used as a proxy for illness onset and ranged from May 10 through October 3, 2013 (Figure). The most commonly reported symptoms included loss of appetite, light-colored stools, dark urine, and jaundice. Median laboratory values reported at the peak of illness were: aspartate aminotransferase 1,128 IU/L (range: 104–2,184, upper limit of normal ~40); alanine transaminase 1,793 IU/L (range: 347–3,091, upper limit of normal ~40); alkaline phosphatase 150 IU/L (range: 68–251, upper limit of normal ~120); and total bilirubin 12.6 mg/dL (range: 2.8–39.6, upper limit of normal ~1.2). Ten patients had liver biopsy data available at the time of this report; seven had histology consistent with hepatitis from drug/toxic injury, with findings including hepatocellular necrosis and cholestasis. Eleven (38%) patients were hospitalized, with a median duration of 7 days (range: 1–45). One patient died, two patients received liver transplants, and two remain hospitalized; all other hospitalized patients have been discharged.

Of the 29 identified patients, 24 (83%) reported using OxyELITE Pro during the 60 days before illness onset. Twelve (41%) reported use of OxyELITE Pro and no other dietary supplement, and 12 (41%) reported use of both OxyELITE Pro and at least one additional dietary supplement. Three (10%) reported using other dietary supplements for weight loss or muscle building, but not OxyELITE Pro. Information about use of OxyELITE Pro is not yet known for two (7%) patients. For twelve patients with specified dates of use, the median duration from starting OxyELITE Pro to the onset of symptoms was 60 days (range: 7–130). There was no other dietary supplement or medication use reported in common by more than two patients.

National case finding efforts have included surveillance of poison center data using the National Poison Data System. A call for cases was also disseminated through the United Network for Organ Sharing listserv to transplant programs across the country. These activities have identified four persons in states outside of Hawaii with reported OxyELITE Pro or other weight loss or muscle-building dietary supplement use prior to the development of acute hepatitis of unknown cause. One of these is a resident of Hawaii who obtained their product in Hawaii but was diagnosed in a different state. CDC, in collaboration with state health departments, is collecting additional clinical and epidemiologic information from these persons to determine if this outbreak is nationwide.

Results from FDA product testing are pending. While the investigation is ongoing and these data are preliminary, clinical data, laboratory tests, and histopathology of liver biopsy specimens collected thus far suggest drug- or herb-induced hepatotoxicity. Drug- and herb-induced hepatotoxicity have been reported in association with exposure to a variety of drugs and herbs used as dietary supplements and can lead to severe acute hepatitis and liver failure (1,2). Drug- and herb-induced hepatotoxicity often resolves following discontinuation of the product (3). Attributing liver injury to a specific ingredient can be challenging because of multiple ingredients, product variability, and lack of testing to confirm exposure to a product. Clinicians evaluating patients with acute hepatitis should ask about consumption of dietary supplements as part of a comprehensive evaluation. Clinicians should report patients meeting the case definition to the local or state health department, as well as the FDA's MedWatch program. Clinicians can discuss patient management options with a medical or clinical toxicologist by calling their local poison center at 1-800-222-1222. Persons who use dietary supplements for weight loss or muscle gain should do so with caution and under a medical provider's close supervision.

http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6240a1.htm

Friday, November 01, 2013

FDA Warning that Pfizer’s Tygacil Increases Risk of Death

News from the FDA on this product:

ISSUE: FDA notified health professionals and their medical care organizations of a new Boxed Warning describing an increased risk  of death when intravenous Tygacil is used for FDA-approved uses as well as for non-approved uses. These changes to the Tygacil Prescribing Information are based on an additional analysis that was conducted for FDA-approved uses after FDA issuing a Drug Safety Communication about this safety concern in September 2010.
This analysis showed a higher risk of death among patients receiving Tygacil compared to other antibacterial drugs: 2.5% (66/2640) vs. 1.8% (48/2628), respectively. The adjusted risk difference for death was 0.6% with corresponding 95% confidence interval (0.0%, 1.2%). In general, the deaths resulted from worsening infections, complications of infection, or other underlying medical conditions.

BACKGROUND: Tygacil is FDA-approved to treat complicated skin and skin structure infections (cSSSI), complicated intra-abdominal infections (cIAI), and community-acquired bacterial pneumonia (CABP).

RECOMMENDATION: Health care professionals should reserve Tygacil for use in situations when alternative treatments are not suitable. 

FDA Asks Ariad to Halt Sale of Leukemia Drug Iclusig

The FDA has asked Ariad Pharmaceuticals to suspend marketing and sales of Iclusig (ponatinib), a chemotherapy agent used to treat leukemia, pending further investigation of reports of a link between the drug and increased risk of "life-threatening blood clots and severe narrowing of blood vessels".
  • Patients currently taking Iclusig who are not responding to the drug should immediately discontinue treatment.
  • Patients who are currently taking Iclusig, who are responding to the drug, and whose healthcare professionals determine that the potential benefits outweigh the risks should be treated under a single-patient Investigational New Drug (IND) application or expanded access registry program while FDA's safety investigation continues.
  • Healthcare professionals should not start treating new patients with Iclusig unless no other treatment options are available and all other available therapies have failed.