Cosmetic drug companies scarred by misbranding

A district court enjoined two individuals and two New Jersey drug companies from distributing unapproved injectable skin whitening drugs. In addition to preventing Flawless Beauty LLC and RDG Imports LLC from distributing the unapproved and misbranded drugs, the injunction requires the companies to recall and destroy all of the unapproved and misbranded injectable skin whitening drugs. The companies and individuals agreed to settle the case and be bound by a permanent injunction.

Complaint

According to the complaint, in addition to making skin whitening claims, the companies’ skin whitening drug products make other unsubstantiated therapeutic claims. For example, some of the products asserted that the drugs “contribute to good liver function” and “clinically treat degenerative brain & liver diseases including Parkinsons.” The complaint also identified public health risks associated with the companies purportedly sterile injectable skin whitening drugs—nerve or blood vessel damage, blood-borne infection, superficial skin infection, cellulitis, abscess formation, and toxic systemic reactions.

The complaint asserted that the products were misbranded because they contained false or misleading information, including the false implication of FDA approval. Other labeling issues identified in the complaint include improper directions for use and the absence of “Rx” on the label.

Injunction. Until the companies meet specific remedial measures, the injunction requires them to stop importing, receiving, manufacturing, preparing, processing, packing, labeling, holding, and/or distributing unapproved drugs. The companies have 20 days to meet the mandate to recall and destroy the unapproved drugs.

FDA considers establishing a new ‘Office of Patient Affairs’

The FDA announced that it is establishing a public docket to solicit public input on ongoing efforts to enhance mechanisms for patient engagement at the agency. In addition, to achieve a more transparent, accessible, and robust experience for patient communities, the FDA is considering establishing a new Office of Patient Affairs.

On November 4, 2014, the FDA established a docket (FDA-2014-N-1698) for the public to submit information related to the FDA’s implementation of the Food and Drug Administration Safety and Innovation Act (FDASIA) (P.L. 112-144), Patient Participation in Medical Product Discussions under FDASIA section 1137.

Based on the comments received, the FDA identified objectives for its patient engagement activities. First, to develop a nuanced understanding of the patient experience of disease by: (1) gathering patient perspective on what is clinically meaningful; (2) assessing attitudes towards benefit-risk and tolerance of uncertainty; and (3) enhancing the science of eliciting and integrating patient input.

Second, to support patients and their advocates in understanding regulatory processes and navigating the FDA by: (1) communicating relevant FDA positions, procedures, and activities; (2) connecting patients and their advocates with the appropriate resources; and (3) resolving discrete challenges and needs.

To achieve these objectives, the FDA is considering establishing a central “Office of Patient Affairs.” The responsibilities of this central office would include:

  • offering a single, central entry point to the FDA for the patient community;
  • providing triage and navigation services for inbound inquiries from patient stakeholders;
  • hosting and maintaining robust data management systems that would incorporate and formalize knowledge shared with the FDA by patient stakeholders and the FDA’s relationships with patient communities; and
  • developing a scalable and forward-looking platform for communicating with patient stakeholders, particularly online channels.

The Office of Patient Affairs would be directly accountable to the medical product Centers. A regular evaluation of this central office and of FDA’s overall patient engagement efforts are also proposed.

 

 

The Empire State woos pharma, biotech industries

The 21st Century Cures Act (Cures Act) was passed by the House on November 30, 2016 and the Senate on December 7, 2016. The President signed it into law on December 13, 2016.  The Cures Act contains three primary titles that makes good on the promise of its name through FDA reforms by accelerating drug and device development and delivery. The Cures Act also creates new administrative positions related to mental health and substance abuse and provides state funding to combat opioid addiction. The President applauded Congress’ approval of the bill, commenting, “I think it indicates the power of this issue and how deeply it touches every family across America.”

In a similar vein, New York Governor Andrew Cuomo and New York City Mayor Bill de Blasio recently unveiled two initiatives that would commit $1.15 billion in funding and tax incentives for education, business development, and job creation in the life sciences sector. Of the total amount,  New York City will be investing $500 million in biotech and life sciences over the next decade via a program called LifeSci NYC, the largest piece is composed of $300 million in tax credits that will be made available to companies building lab space in the city, in order to defray the high costs of construction in the city. The state’s contributions include $250 million in tax incentives for new and existing life science companies, $200 million in state capital grants to support investment in wet-lab and innovation space, and $100 million in investment capital for early stage life science initiatives with an additional match of at least $100 million for operating support from private sector partnerships.

Citing the lack of affordable and appropriate lab space as a barrier to industry, especially in the New York City real estate market, the state and city initiatives will provide more than 3.2 million square feet of innovation space and 1,100 acres of developable land available tax-free at 45 colleges and universities statewide. The availability of grants, land and space would offer an incentive for life science industry to access labs, infrastructure, and other equipment for product development.

 

Second Missouri jury hits J&J with $55M verdict after linking talc to ovarian cancer

Another Missouri jury awarded $55 million to a woman who sued the company over allegations that she developed ovarian cancer after decades of using talc body powder for feminine hygiene. The verdict includes $5 million in actual damages and $50 million in punitive damages, according to a press release issued by Beasley Allen, the law firm representing the woman’s family.

The complaint, which was filed on behalf of over 60 plaintiffs, including the 62-year-old woman, alleged that each woman had developed ovarian cancer as a direct result of using Johnson’s® Baby Powder and its Shower to Shower® body powder—both of which contained talc—for more than 40 years. Specifically, the women all alleged that they had used Johnson & Johnson’s talcum powder products to dust their perineum for feminine hygiene purposes. It was asserted in the case that this was an intended and foreseeable use of these products based on the manufacturer’s advertising, marketing, and labeling of them. It was alleged that her development of ovarian cancer was directly and proximately caused by the unreasonably dangerous and defective talc products and the manufacturer’s “wrongful and negligent conduct in the research, development, testing, manufacture, production, promotion, distribution, marketing, and sale of talcum powder.” According to the timeline outlined in the complaint, Johnson & Johnson knew in 1971 about a study’s suggestion that there was a possible link between ovarian cancer and talc.

It was further alleged that at all pertinent times, cornstarch presented a feasible alternative to the use of talcum powder. Cornstarch is an organic carbohydrate that is quickly broken down by the body with no known health effects. Cornstarch powders have been sold and marketed for the same uses with nearly the same effectiveness.

“This second jury verdict affirms that Johnson & Johnson knew that its talcum powder products posed a risk to women’s health, but they did nothing to warn the public,” said Beasley Allen lawyer Ted Meadows.

Jury’s finding

The jury found Johnson & Johnson and Johnson & Johnson Consumer Companies, Inc. equally liable on the consumer’s claims for product liability failure to warn and negligence, and conspiracy. However, the jury found in favor of these two companies on the woman’s conspiracy claims. The jury also found in favor of Imerys Talc America, Inc., which has been in the business of mining and distributing talcum powder for use in talcum powder-based products, including the products at issue, on the negligence claim (the strict liability failure to warn claim had been withdrawn).

After agreeing that the products contributed to the woman’s development of ovarian cancer, the jury rendered a $55 million verdict for the woman’s family. The verdict included $5 million in actual damages and $50 million in punitive damages ($35 million against Johnson & Johnson; and $15 million against Johnson & Johnson Consumer Companies, Inc.).

Prior verdict

In February, another City of St. Louis Circuit Court jury awarded a woman’s family $72 million after agreeing the products contributed to the development of her ovarian cancer. That verdict included $10 million in actual damages and $62 million in punitive damages (see J&J gets hit with $72M verdict over link between Talc powder and cancer, Health Law Daily, February 26, 2016).