Experienced FDA Compliance Consultants
If you need assistance regarding compliance with the FDA, do not hesitate to contact our team of FDA compliance professionals.
The FDA is a federal agency charged with the responsibility of protecting the public health from dangerous or misleading products and devices. The agency regularly investigates companies who fall short of this mission.
Compliance is a critical component of healthy business operations. Issues with maintaining compliance could lead to FDA investigations and litigation into your company for the failure to follow FDA laws, regulations, and guidance. Do not let this happen to your business.
At Oberheiden, P.C., our team of FDA defense attorneys are experienced in handling internal and external compliance issues as well as negotiating with the FDA.
Our team includes FDA compliance consultants, former FBI agents, former U.S. attorneys, and former prosecutors as well as attorneys with rich backgrounds in private practice. We can help you deal with varying issues of FDA compliance.
Do not wait to get in touch with an FDA defense attorney today. Put Oberheiden, P.C. on your side to defend your business and reputation.
Staying Compliant in 2023
Compliance is a major issue for companies and remains one of the top concerns for the continuity of business operations.
Compliance demonstrates to company personnel that the company has a commitment to following the law. It also demonstrates to federal agencies that the company is making a good faith effort to maintain full compliance with the law.
Failure to maintain compliance with FDA laws, regulations, and guidance could result in substantial penalties—civil and criminal—and reputational harm to the company.
Below we offer five keys to help you stay compliant in 2023:
1. Companies subject to the FDA should regularly evaluate whether their products are consistent with the FDA’s provisions on labeling and advertising.
The Food and Drug Administration (“FDA”) is a federal agency vested with the authority of protecting public health by ensuring that food, drugs, medical device, and other products are safe and do not present a danger to the public.
One of the most common topics the FDA investigates to guarantee its mission involves the labelling and advertising of drug promotions.
Lawful drug promotion is a debatable topic in the nation. Companies engaged in the advertising and promotional labeling of drugs must ensure that they are following the relevant FDA regulations (21 CFR 201-202).
All labeling and advertising of drug promotions should comply with the following three requirements:
- Claims relating the drug must be supported by substantial evidence. “Substantial evidence” refers to the notion that drug claims must involve controlled investigations by experts and professionals qualified by experience and training to evaluate the drug’s safety and effectiveness when concluding that the drug is safe and effective for the public to use.
- Materials for the claim must contain a brief summary of the drug’s prescribing information. All advertisements and promotional material must contain a brief summary that explains the risks of the drugs in the drug’s prescribing information as well as an FDA use of the drug. The brief summary should include who should and should not take the drug; when the drug should be taken; possible side effects; etc.
- Drug product claims must be true and not misleading to consumers. The FDA regulatory investigates companies for drug labeling and advertising that is untruthful and misleading. It is critical that companies ensure that every drug claim is truthful and not misleading and, critically, not false. This means that advertising and promotional material must not be presented in a way that would mislead the public such as by omitting material facts that are otherwise needed for the individual to make an informed decision.
2. Healthcare companies that engage in medical promotion and advertising should make certain that their claims are truthful, not misleading, and substantiated.
Lawful medical promotion and advertising is a complex area that is heavily regulated by the FDA. Healthcare companies need to ensure that all their claims follow FDA laws, regulations, and guidelines.
For instance, the Food Drug and Cosmetic Act (“FDCA”) regulates the advertising of restricted medical devices. It provides that a product is considered “misbranded” if its advertising is false and misleading or if its advertising does not contain a brief description of its intended use, warnings, side effects, etc.
Additionally, the advertising of non-restricted medical devices is regulated by the Federal Trade Commission (“FTC”). The FTC evaluates advertising for these products and focuses on whether they are truthful, not misleading, and are substantiated by competent and reliable scientific evidence.
Companies should focus on the “substantiation” element, which is a debatable element. The policy of the FTC on this point is whether or not the claim relies upon a reasonable basis. In other words, there must be evidence that supports the claim.
Lastly, companies should double check that their promotional materials regarding a drug do not represent or imply that the drug is safer or more effective than another drug where such a claim has not been demonstrated by substantial evidence. These unsubstantiated superiority claims are the subject of many investigations.
3. Companies should stay abreast of new FDA compliance programs.
The FDA monitors companies and their products through its several compliance programs, as listed on its website. These compliance programs give instructions to the FDA staff on how to analyze compliance with federal statutes such as the FDCA.
The FDA’s compliance programs are categorized according to six program areas:
- Biologics (CBER)
- Bioresearch Monitoring (BIMO)
- Devices/Radiological Health (CDRH)
- Drugs (CDER)
- Food and Cosmetics (CFSAN))
- Veterinary Medicine (CVM)
It is important that companies read and evaluate their compliance under these different programs as well as develop strategies on how to overcome identified weaknesses.
4. In an era of significant social media use, companies should continuously ensure that their online content meets FDA guidelines.
Companies today increasingly find it useful to advertise their promotional content on social media platforms. Social media allows companies to interact with the public and advertise content to consumers and providers in a more convenient and highly accessible manner.
For instance, certain internet and social media platforms contain character space limitations. Companies choosing to advertise their products and claims on such platforms must ensure that they are able to incorporate risk information within the character space limitations.
It is recommended that companies provide direct access to a more comprehensive discussion of the product’s risks.
Other requirements include correcting misinformation by third parties.
5. Companies should be extra cautious in complying with FDA guidelines on disease awareness communications, especially in the midst of the coronavirus.
The Office of Prescription Drug Promotion (“OPDP”) is an office within the FDA that aims to ensure that prescription drug promotion is truthful, balanced, and accurately communicated by conducting compliance and education programs as well as by encouraging better communication of labelling and advertising.
It is critical that companies maintain compliance with relevant regulations regarding disease awareness, drug promotions, drug communications, etc.—especially as the coronavirus takes its toll on the nation.
With respect to disease awareness, the OPDP has issued warning letters that describe what is and what is not acceptable behavior. These communications are not subject to the requirements of the FDCA if they properly meet the definition of disease awareness communications.
Disease awareness communications include communications that discuss a disease or health condition but do not mention any specific drug and do not make any representations regarding a particular drug.
If the communication is directed at consumers, it must include an indication that the individual see their doctor for diagnosis and treatment.
However, it is important to understand that if the communication mentions a particular drug, then the communication may be considered “labelling” or “advertising”—which would make it subject to the FDA’s laws and regulations.
Therefore, even implied claims can bring the company’s communications within the purview of the FDA’s regulatory and enforcement authority.
Dr. Nick Oberheiden
Founder
Attorney-at-Law
John W. Sellers
Former Senior Trial Attorney
U.S. Department of Justice
Local Counsel
Joanne Fine DeLena
Former Assistant U.S. Attorney
Local Counsel
Lynette S. Byrd
Former Assistant U.S. Attorney
Partner
Amanda Marshall
Former U.S. Attorney
Local Counsel
Aaron L. Wiley
Former Federal Prosecutor
Local Counsel
Roger Bach
Former Special Agent (OIG)
Gamal Abdel-Hafiz
Former Supervisory Special Agent (FBI)
Chris Quick
Former Special Agent (FBI & IRS-CI)
Kevin M. Sheridan
Former Special Agent (FBI)
Ray Yuen
Former Supervisory Special Agent (FBI)
Dennis A. Wichern
Former Special Agent-in-Charge (DEA)
Need Advice with FDA Compliance?
Failure to maintain FDA compliance is a contributing factor of FDA investigations into companies allegedly engaging in behavior that misleads the public through its advertising, labeling, claims, or other behavior.
The FDA regularly conducts investigations into companies raising certain red flags. It is important now more than ever that companies are aware of the importance of maintaining full compliance with the law.
Do not fall prey to substandard compliance policies. Let Oberheiden, P.C. advise you on your FDA compliance—including how to best prepare you for the upcoming year.
If you have questions regarding FDA compliance or are concerned about a possible FDA investigation, call or contact our team of FDA compliance consultants & lawyers today for a free consultation.
