According to FDA’s announcement, Laclede had a long history of violations with the FDA. In 2012, FDA inspectors found numerous violations of the Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals and other issues surrounding the marketing and sale of unapproved new drugs. As explained by FDA, the company undertook steps to correct the violations, but the Agency deemed the response ineffective. In February 2013, the FDA issued a warning letter to the company for violations of the CGMP and the Federal Food, Drug, and Cosmetic Act (FFDCA) by manufacturing and marketing both over-the-counter (OTC) and prescription drug products without an approved application (unapproved new drugs). According to the FDA Warning Letter, the Agency deemed the products to be drugs due to certain disease claims made in the Company’s marketing materials and since no approved applications were held by the Company, the products were deemed unapproved new drugs. For example, some of the claims at issue included: “Methods and composition for the treatment of vaginal diseases employing peroxide-producing enzymes and peroxidases,” “Helps Prevent The Causes Of Vaginosis, Yeast Infection and Bad Odor,” and “Probiotics: Potential to Prevent HIV and Sexually Transmitted Infections in Women.” Accordingly, the Company’s labeling was one of the major issues that led to FDA’s finding of unapproved new drugs, prompting FDA enforcement action.

On June 25, 2014, the FDA filed for a permanent injunction , as the Agency argued that the Company’s operations remained non-compliant with FDA regulations. That injunction was granted on January 30, 2015. One of the main issues here was Laclede’s failure to properly label their products. The consent decree for permanent injunction specifies that Laclede may not market any products with the words “prebiotic” or “actibiotic” on its labels or packages without first obtaining the FDA’s approval. In addition, Laclede may not market any products referencing “lubrication” without appropriate FDA approval.

In sum, properly labeling products is one of the most critical steps in the product development process. Compliance with the regulations is a must to ensure that your products stay on the shelf and that your company is not the subject of FDA enforcement action. Our firm offers comprehensive label reviews and packaging requirement assistance to help our clients ensure that their products are fully compliant with all applicable rules and regulations. If you would like assistance with your products, please contact us at contact@sglawfl.com.

As we previously reported, on May 16, 2014, representatives from the U.S. Marshals Service had seized more than $11 million worth of unapproved drugs held by Masters Pharmaceuticals of Ohio and marketed by Ascend Laboratories of New Jersey. The U.S. Marshals seized urea cream 39%, hydrocortisone acetate suppositories 25 mg, urea cream 40%, pramoxine-HC otic drops, and urea lotion 40%. The FDA and U.S. Attorney for the Southern District of Ohio requested the seizure because the drugs were not marketed in accordance with FDA regulations, in that they were marketed for conditions that caused them to be deemed drugs but the Company had not secured the necessary FDA approval for the products.

The pramoxine-HC drops were intended to control itching and treat external ear infections caused by bacteria. Ascend Laboratories allegedly marketed the hydrocortisone acetate suppositories for the relief of symptoms caused by ulcerative colitis, inflamed hemorrhoids, and other inflammatory conditions. All three urea-containing products were intended to treat dermatitis, eczema, and other conditions that cause thickening of the skin.

Because none of these products have been proven safe or effective for their intended uses, i.e., obtained FDA approval for the treatment of these diseases and/or conditions, the FDA filed a Complaint alleging that the drugs were misbranded under the Federal Food, Drug, and Cosmetic Act. The complaint came approximately six months after an inspection revealed Ascend Laboratories was allegedly marketing certain products for the treatment of diseases and/or conditions without obtaining FDA approval.

The FDA’s announcement of this seizure explains that these drugs were seized under the Marketed Unapproved Drugs Compliance Policy Guide, which states that any unapproved new drug first marketed after September 19, 2011 is subject to immediate enforcement action even if the marketer never received a prior warning from the FDA. The FDA Compliance Policy Guide for unapproved marketed drugs lists several enforcement priorities. The first two priorities are drugs with potential safety risks and drugs that lack evidence of effectiveness. The FDA is also taking enforcement action against the marketers of so-called health fraud drugs. These products are represented as effective for diagnosing, preventing, curing, or treating diseases, but they have not been scientifically proven safe or effective for their intended purposes.

Drug manufacturers and marketers are subject to close scrutiny under the FDA’s guidelines. The agency has the right to seize drugs and other medical products without any prior warning, putting businesses in this industry at risk for serious losses. If you have any questions about FDA approval or you need help responding to a complaint filed by the FDA, contact us at contact@sglawfl.com.

The action taken against Ascend Laboratories and Masters Pharmaceuticals (“the Companies”) was taken as a follow up to a November 2013 inspection of Ascend, which found that these products had been marketed in the absence of an FDA-approved drug application. The inspection further found that these products were misbranded and were being sold contrary to the guidance provided by the FDA for the proper labeling and marketing of a drug or cosmetic.

The FDA took action by filing a complaint in the U.S. District Court for the Southern District of Ohio, citing that the Companies violated the provisions of the Federal Food, Drug and Cosmetic Act (“FFDCA”) found in Title 21, Code of Federal Regulations as promulgated under 21 U.S.C. 321 and 387. Under FFDCA and accompanying FDA regulations, products that intended to be used in the diagnosis, cure, treatment or prevention of a disease or condition are considered drugs. As noted in this case, the Companies marketed products for various diseases and/or conditions, including hemorrhoids, colitis and eczema. Further, while the FDA did not allege the products themselves contained active pharmaceutical ingredients, it was the statements made in marketing that caused the products to be deemed unapproved new drugs. Accordingly, it is important to ensure compliance with certain marketing limitations in order to avoid misbranding and other FDA violations.

In sum, this case illustrates the importance of ensuring that the marketing materials of FDA-regulated products, including websites, print media and product labels, are properly worded because statements made in marketing play a key role in determining how FDA-regulated products are regulated. Second, this case illustrates the importance of being responsive and remaining committed to taking all necessary corrective actions after deficiencies are alleged, as the Agency will pursue legal action for violations of the laws and regulations it enforces.

If you have any questions about the FDA’s food, drug and cosmetic regulations or how you can maintain compliance with these regulations, please contact us at contact@sglawfl.com.

Mutual is a Pennsylvania company that markets sulindac tablets, an anti-inflammatory drug. Sulindac tablets are the generic version of the brand-name drug Clinoril. Ms. Bartlett suffered permanent injuries after taking the sulindac tablets, and brought a design-defect lawsuit against Mutual pursuant to New Hampshire state law. The district court awarded compensatory damages to Ms. Bartlett. Mutual appealed, and the U.S. Court of Appeals for the First Circuit affirmed the district court’s decision. The Supreme Court granted certiorari on November 30, 2012.

Mutual markets the sulindac tablets under an Abbreviated New Drug Application (“ANDA”) that was approved by the U.S. Food and Drug Administration (“FDA”) in 1991. Unlike a New Drug Application (“NDA”), an ANDA does not require that a drug sponsor submit any preclinical or clinical testing data. All generic drugs under an ANDA, however, must be bioequivalent, or chemically identical, to an innovator drug already approved by an NDA.

Of primary focus in this case is whether states are allowed to impose liability on a generic drug manufacturer for a defective design. In a similar case, PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), the Supreme Court held that federal law precludes a state failure-to-warn claim against generic drug products because FDCA regulations require that a generic drug has the same label as the brand name drug. Since a generic drug manufacturer is not allowed to alter a drug’s label, the court found that a company would be unable to comply with the state duty to warn without violating federal law.

Mutual argues that Mensing is applicable to design-defect claims as well. According to Mutual, the FDCA requirement that a generic drug product be the bioequivalent of the brand name drug, with identical active ingredients, precludes any design-defect lawsuits targeting generic drugs.

Ms. Bartlett argues, and the First Circuit agreed, however, that Mensing is not applicable to design-defect claims. Previously, in Wyeth v. Levine, 555 U.S. 555 (2009), the Supreme Court held that the FDCA does not preempt a state law failure-to-warn claim against a brand name drug. The First Circuit’s opinion explains that the later holding in Mensing only requires an exception for a failure-to-warn allegation against a generic drug. Additionally, according to the court, a generic drug manufacturer can avoid liability by not making the product if the risk outweighs the benefits to consumers.

In sum, the Supreme Court is not expected to issue an opinion in the case until June. If you have any questions about the requirements for generic drugs or the drug approval process, please contact us at contact@sglawfl.com.

Overactive bladder, a condition where the bladder squeezes too often or without warning, affects up to 33 million Americans annually, and the majority of the afflicted are women.  The active ingredient in the Oxytol is called Oxybutynin, which belongs to a class of drugs known as anticholinergics.  It has the distinction of being the first drug from this class made available for over the counter treatment (“OTC”) for overactive bladder. 

When the original Federal Food, Drug and Cosmetic Act was enacted in 1938, there was no clear distinction between OTC drugs and prescription drugs. It was not until 1951, with the passage of the Durham-Humphrey amendments, that this issue was addressed and specific standards for classification of OTC drugs were created. The Durham-Humphrey amendments required that drugs that are not likely to be used safely without supervision from a doctor be dispensed by prescription only.  These prescription-only drugs were essentially deemed unsafe as they were believed to be habit-forming, toxic, have the pote

ntial for harmful side effects, or are for the treatment of maladies that cannot be diagnosed by a layman. The Durham-Humphrey amendments also provided that all other drugs that do not meet the criteria for unsafe drugs can be sold OTC.

The process of taking a drug from prescription to OTC status is called an “Rx to OTC switch.” This switch can happen in two ways, either by a manufacturer’s submission of additional information about the drug or by an “OTC drug review.” In 1972, OTC drug review began in order to review on an ongoing basis the safety and effectiveness of all drugs that are permitted for non-prescription use.  Through the OTC drug review process, experts in the field then will review the active ingredients to determine if they are indeed safe and effective. The second way a drug is approved for OTC use is through the new drug application process. Under this process, the manufacturer must submit information to the FDA that clearly shows the drug is appropriate for self-administration. Often, the information will include the submittal of studies showing that the product label can be easily read and understood by the consumer without the aid of a healthcare professional. More information about the Rx to OTC switch process may be accessed here.

If you have additional questions with Rx to OTC switch process or the FDA’s regulation of drugs, please contact us at contact@sglawfl.com.

]]> https://giannamore-law.com/fda-approves-levaquin-for-treatment-of-plague-through-animal-efficacy-rule/?utm_source=rss&utm_medium=rss&utm_campaign=fda-approves-levaquin-for-treatment-of-plague-through-animal-efficacy-rule Tue, 01 May 2012 06:19:56 +0000 http://giannamore-law.com/?p=127 On April 27, 2012, the U.S. Food and Drug Administration (“FDA”) approved Levaquin (levofloxacin), a drug used to treat those afflicted with plague. In addition to treating those with the deadly infection, Levaquin is also approved to reduce the risk of contracting plague after exposure to Yersinia pestis, the bacteria responsible for causing the disease. Although the FDA estimates that only 1,000 to 2,000 people worldwide contract the infection each year, the Agency is interested in expanding available treatment options for the disease based on its belief that it could potentially be used as a bioterrorism agent in the future. More information about Levaquin may be accessed here.

Interestingly, Levaquin was approved based on a single efficacy study conducted with African green monkeys. As discussed in the Agency’s announcement of the approval, Levaquin was approved through the application of the FDA’s Animal Efficacy Rule. Found at 21 C.F.R. § 314.610, the Rule allows the FDA to grant marketing approval for new drug products for which safety has been demonstrated using animal studies alone. The Rule allows for FDA approval based solely on animal studies only when the effect demonstrated in the animal species is a predictive result for humans and it is not otherwise feasible or ethical to test the safety and effectiveness of the drug with human subjects. In addition to other postmarketing requirements, all human recipients of drugs approved under the Animal Efficacy Rule must be notified, via product labeling, that the drugs’ approval was based solely on animal efficacy studies.

Under the FDA’s regulatory regime, drug sponsors must demonstrate that a drug is safe and effective for its intended use in order to support a New Drug Application (“NDA”). According to the FDA, the safety and effectiveness of Stendra was demonstrated through three double-blind, placebo-controlled studies. While there is no one standard for how safety and effectiveness may be demonstrated, the FDA often requires drug sponsors to perform animal studies and/or human clinical trials to ensure that the benefits of such drugs outweigh the risks. More information about the NDA process may be accessed here.