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FDA Compliance Lawyers

June 22, 2020

Food and Drug Administration Compliance

Is your company thoroughly compliant with FDA laws? The U.S. Food and Drug Administration (FDA) has broad oversight and enforcement authority, and businesses that neglect compliance can face substantial penalties. Our federal compliance attorneys represent food, drug, medical testing, medical devices, and other companies throughout the United States.

 

Interacting with the U.S. Food and Drug Administration (FDA) is par for the course when doing business in a variety of different sectors. From applying for approvals to enduring inspections and managing recalls, there are many aspects to FDA compliance.  Every company needs to have not only full comprehension of their obligations, but also a clear strategy for meeting these requirements effectively.

 

Our attorneys serve as FDA compliance counsel to businesses nationwide. Our client roster includes companies that manufacture and sell products and services in industries that come within the FDA’s jurisdiction.  The list includes businesses in prescription and over-the-counter (OTC) medications, biologics, medical tests, medical devices, medical software, foods, dietary supplements, food additives, and cosmetics. We have lawyers on staff with specific experience with health care-related products and services including genetic cancer screenings, cannabidiol (CBD) products, and compounded medications. Every one of our attorneys, investigators, and consultants are very well versed in the FDA’s rules, regulations, and investigative practices.

 

Comprehensive Services in FDA Compliance: Don’t Allow Oversights to Put Your Company at Risk

As is the case with all other aspects of corporate compliance, compliance with FDA laws requires a nuanced and detail-oriented approach. To craft an effective in-house FDA compliance program, it is essential to gain not only a clear understanding of the Food, Drug, and Cosmetic Act (FDCA) and other statutes and regulations that fall under FDA’s jurisdiction, but also a clear understanding of your company’s products, services, and business practices that raise FDA compliance implications.

 

In our representation of clients with regard to FDA compliance, our attorneys, investigators, and consultants liaise closely with the company’s executive team, in-house counsel, subject-matter experts, and other relevant staff members to assess the company’s gaps and risks. As soon as we develop a clear picture of the company’s needs, we can start the process of helping our client reach full compliance efficiently with no wastage of company resources. With this approach, we are able to furnish comprehensive and cost-effective compliance representation at a small percentage of the cost charged by the majority of the other firms.

 

What Will Your Company Require In Order to Avoid Unwanted FDA Scrutiny?

Whether you have questions about a specific compliance problem or you are in need of a total FDA compliance program created from scratch, our lawyers are prepared to guide you with sound advice based on real-world expertise. Our suite of FDA compliance services include:

 

Counseling in FDA Compliance

We work daily with our clients on a host of compliance issues. If you are operating under a compliance regiment created by our firm or you have previously had FDA compliance counsel, we can help you with prompt, insightful, and actionable advice as needed you need it. As a result of our attorneys’ wealth of experience in the field, we are capable of quickly answering numerous questions that would necessitate hours of research at other law firms.

 

Development and Implementation of Your In-House Compliance Program

For businesses that must  develop comprehensive FDA compliance programs from the baseline or retool their outdated or ineffective compliance regiments, we can furnish full-service representation from strategizing and planning through documentation and implementation. The FDA compliance programs we implement for our clients are totally custom-tailored.  Each one is designed to ensure not only that our clients’ companies are compliant, but that they will be ready to efficiently prove their compliance in the event of an FDA inquiry or investigation. We help our clients with:

 

  • FDA-specific Policy and Procedure Development
  • Incorporation of FDA-specific jargon into employee codes of conduct and other institutional documentation
  • Management of workflow and processes to ensure FDA-related issues are addressed in a timely fashion at all stages of product development, commercialization, and distribution
  • Employee training tailored to specific roles within the company
  • Implementation and testing of the compliance program, and fine-tuning of relevant processes and procedures
  • Continual documentation of FDA compliance efforts and practices

 

Product Sampling, Licensing, and Distribution

Three areas in particular where even the most well-intentioned businesses can get into trouble are sampling, licensing, and distribution. Our compliance team can provide you with advice with regards to the legal implications involved and the steps necessary in order to conduct sampling and to license and distribute your company’s products without coming under fire from the FDA.

 

Product Marketing and Scientific Claims

When bringing a product to market, gaining FDA approval is not the end of the road when it comes to the agency’s oversight. Marketing of FDA-approved products is a common area of contention for companies as well—specifically, complying with the limits on scientific claims. In order to make a scientific claim (or even a statement that is arguably a scientific claim) about  efficacy of our product, its benefits, or its comparative features, it is obligatory to have adequate substantiation. The FDA customarily initiates enforcement actions against organizations which it believes have not adequately substantiated their scientific claims about the products they market.

 

FDA Notification and Adverse Event Response

If an adverse event should occur, an effective response is paramount. We help clients with all aspects of adverse event response, from carrying out attorney-client-privileged risk assessments to liaising with the FDA. With several former federal prosecutors and Special Agents on our staff, we have people available with first-hand knowledge of how the FDA,the U.S. Department of Justice (DOJ),  the Federal Bureau of Investigation (FBI), and other federal agencies handle these kinds of situations, and we will employ our insights to help you make informed tactical decisions that protect your company’s bottom line.

 

Monitoring, Auditing, and Enforcement

Wisebusiness owners continuously monitor their FDA compliance efforts, and from time to time they must conduct internal audits in order to reassess their compliance needs. Our attorneys, investigators, and consultants can carry out these efforts independently or working in collaboration with your in-house legal department. We can advise you with regards to enforcement and employee discipline as and when necessary.

 

Ongoing Compliance Modifications and Updates

The FDA frequently updates its compliance policies; and because of this, FDA compliance is a moving target. Our lawyers make it their business to remain up-to-date on the latest developments in FDA compliance, and we can notify you proactively when changes to your company’s policies or procedures are required. Despite the fact that updates are issued so consistently, the FDA does not provide any leniency for companies that fall behind. We can make sure that you are not blindsided by a compliance requirement that you were entirely unaware of.

 

Beyond the FDA: Additional Concerns in Compliance for Companies Subject to FDA Oversight

In general, companies that are subject to oversight by the FDA will be subject to the oversight of numerous other federal agencies also. In addition, companies that don’t manufacture or distribute dietary supplements, medications, medical devices, or other products that require FDA approval can still come under FDA scrutiny in a variety of circumstances. Whether as a result of a contractual relationship or as a result of marketing a third-party product or service, all types of corporations and health care providers can face a slew of federal compliance obligations.  Our lawyers’ and consultants’ past government experience affords us unique insight into this complicated area of corporate compliance.

 

Further than product approvals, substantiation of marketing claims, adverse event reporting, and other FDA-specific compliance concerns, we also regularly advise our clients in such  matters as:

 

  • Health care fraud compliance, including Stark and Anti-Kickback Law compliance in relation to the sale of FDA-regulated medications and medical devices
  • Antitrust compliance in relation to third-party agreements that raise questions about competitive restrictions, market splitting, and other practices that are harmful to consumers
  • Compliance with Federal Trade Commission (FTC) with regards to false marketing claims and allegations of deceptive consumer advertising
  • Compliance with Securities and Exchange Commission (SEC) as it pertains to publishing false or misleading information about FDA approvals, clinical trial results, and other matters that have the potential to influence investment decisions
  • Data privacy and security (companies that store the personally identifying information (PII)  of study participants and customers’ and that collect website visitors’ information online are subject to myriad state, federal, and international data privacy and security requirements)
  • Investigations by the FBI and the DOJ when compliance issues result in federal investigations, these agencies will often help in FDA inquiries

 

Where you need assistance negotiating agreements for the licensing and distribution of FDA-approved products or help preparing and submitting regulatory filings, our lawyers can do all that is necessary for the purpose of protecting your company against undue exposure to FDA and other federal agency inquiries. Because shortcomings have the potential to trigger civil enforcement action and possibly even criminal prosecution, companies and their leaders need to make federal compliance a top priority. This begins with hiring experienced legal representation; and, at Spodek Law Group, we are fully prepared to take responsibility for guiding you and your company to safety.

 

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