False promises rebuked by FDA, no tea or vitamin can cure cancer

Bogus cancer “treatments” being marketing and sold without FDA approval were the target of 14 warning letters and four online advisory letters, according to a press release and consumer update from the agency. The 65-plus products listed by the agency include pills, tablets, creams, syrups, sprays, oils, salves, teas, and medical devices, claiming to cure cancer in humans and pets, and have been found illegally for sale online, in retail stores, at flea markets and swap meets, and even at trade shows.

The FDA called these illegal products a “cruel deception,” and urged consumers to stay away from products that have not passed the agency’s review process, designed to ensure the safety and effectiveness of treatments. It listed the following phases or concepts as warning signs that the advertised product was unlikely to be approved by the agency:

  • treats all forms of cancer;
  • miraculously kills cancer cells and tumors;
  • shrinks malignant tumors;
  • selectively kills cancer cells;
  • more effective than chemotherapy;
  • attacks cancer cells, leaving healthy cells intact; or
  • cures cancer.

Additionally, many of the products that were the subject of the warnings were advertised as “natural” or “non-toxic.”

The warning and advisory letters ask the recipient companies to provide written responses to the violations covered in the letters; if the companies fail to respond and make adequate corrections, they could be subject to further actions including criminal prosecution. According to the FDA, the best scenario for consumers who have purchased or used these products is ineffectiveness. It is possible, however, that these products could interfere with proven, beneficial treatments, or even cause direct harm.

Too much ‘noise’ in system at root of device recall delays

Postmarket surveillance of medical devices, which includes device manufacturers’ investigations of complaints about their devices, are generally not logged in the FDA’s adverse event report system. In a study sponsored by the University of Minnesota and published in the journal Production and Operations Management, the researchers found that the more adverse event reports there are for a ­particular device, the more likely it was a company would have “under-reaction” bias in deciding whether a recall was appropriate.  In other words, device manufacturers, when presented with multiple adverse event reports for a specific device, actually took longer to react on the recall decision.

Each year, the FDA receives several hundred thousand medical device reports (MDRs) of suspected device-associated deaths, serious injuries, and malfunctions. The FDA uses MDRs to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products. A Manufacturer and User Facility Device Experience (MAUDE) database houses these MDRs submitted to the FDA by mandatory reporters (manufacturers, importers, and device user facilities) and voluntary reporters, such as health care professionals, patients and consumers.

Although MDRs are a valuable source of information, they provide only a passive surveillance system. Limitations include the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use. Because of this, MDRs comprise only one of the FDA’s several important postmarket surveillance data sources. As the researchers applied digital analytics to millions of medical device product reports and recall records for their study, they found a high “signal to noise” ratio correlated with the delays. Not only did these indicators create detection issues, older and widely used devices tended to have multiple adverse event reports in MAUDE, making safety-signal detection difficult.

In 2012, the FDA announced plans to develop a National Evaluation System for Health Technology (NEST) to generate better evidence for regulation and agency decisions throughout the lifespan of a device. Whether the system will provide a better way for both the agency and industry to monitor postmarket safety of medical devices is indeterminate, but the FDA is counting on the system providing more collaboration than the current one.

FDA issues sunscreen safety and effectiveness guidances

The FDA issued two final guidance documents dealing with safety and effectiveness data submissions related to nonprescription sunscreen drug products. The guidances detail the data requirements that will allow the FDA to determine whether an over-the-counter (OTC) sunscreen active ingredient or combination of ingredients is generally recognized as safe and effective (GRASE) as evaluated under the Sunscreen Innovation Act (SIA) (21 U.S.C. Ch. 9, Sub. 5, Part I), and requirements governing the content and format of submissions. The final guidances replace draft guidances issued in 2015 (see FDA puts sunscreen safety on thick with four new guidance documents, November 23, 2015).

When the FDA determines that an active ingredient is GRASE and not misbranded for use in nonprescription sunscreens, it issues a final sunscreen order listing the requirements that sunscreen products containing the active ingredient must meet to be marketed without an approved new drug application (NDA). Active ingredients determined to be GRASE may be included in different formulations marketed without product-specific review and approval.

Safety and effectiveness

In “Nonprescription Sunscreen Drug Products: Safety and Effectiveness Data,” the FDA describes its approach to nonclinical safety testing in its evaluation of nonprescription sunscreen active ingredients as focusing on potential long-term adverse effects or effects not otherwise readily detected from human use. The agency generally expects sponsors to submit data from human irritation studies, human skin sensitization studies, and human photosafety studies. It recommends that sponsors provide data from a maximal usage trial (MUsT) “designed to capture the effect of maximal use on absorption into the blood with standard pharmacokinetic assessments.” The FDA will take pediatric differences into consideration. It also recommends that sponsors conduct carcinogenicity studies for any pharmaceutical either with an expected continuous clinical use of at least six months or with an expected clinical use of a minimum of six months in an intermittent manner, and developmental and reproductive toxicity (DART) studies. Sponsors should also collect animal toxicokinetic data. The FDA requests that sponsors include specific postmarketing safety information, including, among other items, summaries of potentially associated serious and nonserious adverse drug experiences and expected or frequently reported side effects.

It also requests that sponsors provide evidence from at least two SPF studies demonstrating that the active ingredient effectively prevents sunburn. The FDA currently requires final formulation testing to ensure the effectiveness of OTC sunscreen products, but anticipates that final sunscreen orders will also include conditions requiring final formulation testing to ensure the safety of permitted sunscreen formulations.

Format and content

Nonprescription Sunscreen Drug Products: Format and Content of Data Submissions,” detailed format and content guidelines for sponsor requests for GRASE recommendations for active OTC sunscreen ingredients submitted under section 586A (586A request) of the federal Food, Drug, and Cosmetic Act (FDC Act) (21 U.S.C. §360fff-1), as amended by the SIA, or in support of a pending request. The guidance outlined specific timeline requirements for submissions and FDA responses once the FDA determines that an application is sufficiently complete to allow the agency to perform a GRASE review. If the agency determines that an application is insufficient, it may refuse to begin the GRASE review.

The guidance lists the characteristics of a complete submission, which include, among other qualities, a single submission for an active ingredient including all data on which a sponsor chooses to rely and specific references and copies of or links to referenced documents. The FDA encourages electronic submissions. The guidance provides a specific structure that it would like sponsors to follow in their submissions. It also includes a detailed list of submissions characteristics that could cause the FDA to refuse to file a data submission, such as disorganization and electronic submissions that cannot be easily opened or navigated.

FTC sets enforcement policy for homeopathic drug labeling claims

Efficacy and safety claims made on over the counter (OTC) homeopathic drug labeling must be substantiated by reliable scientific evidence, according to an enforcement policy statement on the marketing of OTC homeopathic drugs released by the Federal Trade Commission (FTC). The policy statement notes that qualified efficacy and safety claims must clearly indicate: (1) there is no scientific evidence that the product works and (2) the product’s claims are based only on theories of homeopathy from the 1700s that are not accepted by most modern medical experts. The policy statement indicates that the FTC will enforce OTC homeopathic drug labeling no differently than it does any other health products.

Homeopathy

The homeopathic theory is premised on the belief that disease can be treated by small doses of substances, which, in larger doses, produce in healthy individuals, symptoms similar to the disease. However, homeopathic products are often diluted so that the “therapeutic” substance is below a detectable level. Homeopathic theory states the more a substance is diluted, the more potent it becomes. The theory is not accepted by most modern medical experts. As a result, marketing claims for homeopathic remedies have a tendency to be misleading, in violation of federal law.

Enforcement

Section 5 of the Federal Trade Commission Act (FTC Act) (15 U.S.C. § 45(a)(2)), which applies to both advertising and labeling, prohibits unfair or deceptive acts or practices in or affecting commerce, such as the deceptive advertising or labeling of OTC drugs. Due to the significant expansion of the homeopathic industry over the last few decades—growth from a multimillion-dollar market to a more than billion-dollar market—the FTC held a workshop in 2015 to better comprehend the homeopathic marketplace. The workshop was focused on assisting the agency with understanding its legal authority with respect to the advertising and marketing of OTC homeopathic drugs.

Disclosures

The policy statement notes that disclosures regarding the absence of scientific evidence should be prominent and in close proximity to any statement about the product’s efficacy. Depending upon the strength of the efficacy statement, the FTC indicated that the disclosure might need to be incorporated into the efficacy message, itself. Additionally, the policy statement warns marketers of homeopathic drugs not to make statements which undercut those disclosures because the FTC will scrutinize the “net impression” of OTC homeopathic marketing claims when determining whether a marketer has violated the FTC Act.