If you go “off label” with advertising and promotion, FDA’s hammer can hit hard and seemingly out of the blue. Advertising and promotion for devices is weak and lacks legal clarity. For drugs, the regulations are prescriptive and guidance documents clamp down on nuances. Marketing and regulatory affairs departments must collaborate to avoid the hammer and penalties of FDA. The roadblock, however is that marketing managers and regulatory affairs managers rarely reach common ground and are loathe to even consult with each other.
FDA’s Center for Devices and Radiological Health (CDRH) has never issued a comprehensive guidance on advertising and promotion. You are on your own. In contrast, FDA’s Center for Drug Evaluation and Research (CDER) uses long-standing regulations and a growing number of guidance documents in its regulatory approach. Policing social media has become a new regulatory responsibility and FDA is still trying to figure out how to deal with it. Bottom line, do you know when you fail to meet FDA’s requirements or are you guessing? Can you afford to guess? The cost to your business and the confusion left in your customers’ mind becomes an unwelcomed nightmare.
In this seminar, you will learn how to navigate FDA’s numerous legal options and how to interpret them based on basic legal principles. Applying new guidance documents becomes a new test of the FDA’s legal boundaries and enforcement options. The agency is now conducting clinical studies and applies the principles of cognitive psychology to aid in its determination of what a message really conveys. This academic discipline may or may not get to the root of what consumers take away as the message.
Congress and the new FDA Commissioner seem more sympathetic to expanding access to medical treatment before all the conclusive evidence for safety and effectiveness is evaluated by the FDA. Valid off-label information may take the lead in that direction.
This conference will provide insight on how to manage your marketing activity and gauge what regulatory risks your business is willing to accept. You will learn how corporate management requires cooperation between marketing, regulatory affairs, legal counsel, manufacturing, engineering and finance departments. Operating in a stovepipe environment will not work. You need to understand that a weak link in any department leaves the entire corporation vulnerable to FDA enforcement. Most importantly, you will understand the boundaries that FDA uses and how easy it is to cross them. With information from this course, you can step back and rationally evaluate your firm’s regulatory profile for advertising and promotion practices.
- Sales and Marketing executives and managers
- Regulatory Managers
- In-house Legal Counsel and Contract Specialists
- 3rd party consultants
- Venture Capitalists
- Business Acquisition Executives
- Owners of New or Developing Firms
- Own label distributors
- International Trade Managers
- Product specification developers
How easy it is to cross them
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The beginnings of all that the USFDA regulates can be traced right to the early decades of the founding of the nation. In a sense, the FDA, even if came to be called by that formal name much later; embodies the discipline and value set that the new created nation sought to represent. Regulation of all aspects of American life was deeply ingrained very early in the nation’s history, and the FDA was one of prime institutions that played a part in making this happen.
How has the FDA evolved and shaped up over the years? What are the important milestones of this history? This makes interesting reading, because the USFDA has had the kind of history whose colorfulness is matched by few other regulatory agencies around the world.
An indication of the extent to which the FDA attaches importance to ensuring the wellbeing of the American people can be gauged from the fact that the food and other products that this agency regulates account for a fifth of the total money that the nation’s consumers spend. Just its budget – well over four billion in 2014 – is a good indicator to the way in which the FDA has spread its influence in the various spheres of American life. It regulates almost all food items with the exception of meat and poultry.
This situation has not been reached accidentally or overnight. The FDA has by and large kept pace with the developments in the areas it regulates. This was largely true till the advent of very recent technology-led areas such as biotechnology and the social media, where too, the FDA has been trying to put its best foot forward.
The start of formal regulation
A look at the history of the FDA points to the year 1848 as the start of the first formal aspects of regulatory history. That was the year in which Lewis Caleb Beck took his appointment with the Patent Office. His mandate was to chemically analyze agricultural products. This is considered as the first task that was aimed at regulating a product that people consumed. This function rolled over to the Department of Agriculture, which was created in 1862.
The Act of 1906The next step in solidifying the regulatory aspects of life in the US was taken in 1906, with the promulgation of the Pure Food and Drugs Act in 1906. Stretching to some two decades of wrangling between the American Congress and the food industry to formulate, the Act of 1906 sought to prohibit adulterated and misbranded food and drugs from interstate commerce.
The 1938 Food, Drug, and Cosmetic ActThe next major milestone in the aspects of regulatory history in the US took place in 1938. The 1938 Food, Drug, and Cosmetic Act prescribed and detailed the legal requirements for products the FDA – which this Act created – regulated. In this Act, one can trace the earliest tidings of a major activity that the FDA has been carrying out since then: Prescribing the requirements for ensuring quality by prohibiting false claims by manufacturers and advertisers.
President Franklin D. Roosevelt signing the 1938 Food, Drug, and Cosmetic Act.
Over time, the 1938 Act expanded to include more areas such as cosmetics, devices and veterinary medicines, thus strengthening the foundation for regulation and making it more expansive. Since the passage of the 1938 Food, Drug, and Cosmetic Act; two major events happened on the regulatory scene. The outbreak of tetanus and diphtheria diseases in the 1960’s compelled the FDA to take a more proactive approach to vaccinations.
Another major, earthshaking event was the tragedy that thalidomide unleashed on Europe in the 1960’s, which stunted the growth of hundreds of children, which was mainly due to regulatory lapse. This did not happen in the US, mainly because of the efforts and diligence shown by Frances Kelsey, in her role as FDA reviewer. Frances plainly refused to approve thalidomide because she was not convinced about its safety, an act which made her a cult figure in FDA and American and Canadian medicinal history till her death in 2015.
Aspects of regulatory history in the US in the 1990’sFollowing the 1960’s, the next major milestone in the aspects of regulatory history in the US happened in 1990, when the Nutrition Labeling and Education Act was passed. This law was important because it changed the American perspective of labeling of products in the food and pharmaceutical industries. The Nutrition Labeling and Education Act requires manufacturers to provide nutritional information about products on their labels, with the caveat that false labeling information will lead to consequences.
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Good Documentation Practices are the soul of many regulated industries. The FDA, like all other regulatory agencies, makes GDP a central element of its regulations, and bases it on the principle of evidence. For the FDA and other regulatory agencies across the world, what is not documented is nonexistent.
Good Documentation Practices are essential for a number of disciplines. The soul of documentation is, naturally, the written word. What happens when something that happened is not actually written down? It is a work of no practical use, because apart from those that carried out the particular undocumented task; no one else is aware of it. And even when the people who did that task or were witness to it are prone to have their own interpretation and perception of what was done. This is why proof in the form of writing is the most important element of Good Documentation Practices.
What to write, and how toGDP should not only be about just writing down; it is about what to write and also, how, meaning, in what manner. If there has been an intervention in any method of manufacture or any other activity in the regulated industries; the change should be noted down in the proper format as prescribed by the FDA. This enables everyone concerned, from the people in the organization to the auditors to the regulatory agencies, to clearly identify what action was carried out, by whom and when. This further leads to a discovery of the impact of the actions. This is the key to determining the effectiveness of the application of the GDP principles in the particular case.
This is why the FDA has very clear-cut requirements and expectations of GDP from the industries it regulates. These clearly explain the method by which to document the said document, the ways of doing it, and what actions to take when the need arises.
Quality Assurance is unthinkable without the application of GDP principles. The main reason for establishing GDP is ensure that the documentation does the following to the record in question:
What needs to be documented?Another major element of GDP is to determine what is to be documented. The FDA and other regulatory agencies require the principles of Good Documentation Practices to be applied across a number of activities at different stages. These include:
The EMA’s requirements
The EMA also has clear-cut guidelines on Good Documentation Practices. Some of its core requirements relate to
- All aspects of the manufacturing including the product’s formulae, the way in which the processing was done, the methods of its packaging, and the extent to which its testing instructions are written down
- Technical agreements
Further, most regulatory agencies have their own requirements with regard to the styling, ways by which the amendments, if any, need to be jotted down, the type of ink to be used, the way in which the review, if any, needs to be entered, and who should put signatures and where, so on. Manufacturers who fall under the purview of respective regulatory agencies need to adhere to these.
And, for other reasons, as wellImplementing Good Documentation Practices is a great idea to have for meeting regulatory requirements, because companies that do not meet these requirements are in a spot of bother about a number of issues. However, in addition to this, there is also the need for maintaining GDP for business reasons, as well. A business that complies with the requirements set out by the FDA or other regulatory agencies in relation to Good laboratory practices, the CFR regulations such as 21 CFR Parts that apply to various industries, and also as required as part of national and global agencies; earns a good name in the market and is considered a reliable company.
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As the primary regulator of the biological, healthcare, life sciences and other related industries; the FDA has power and authority over how its work is carried out. FDA Warning Letters are among the primary mediums through which it enforces its authority.
The FDA issues a Warning Letter to a company when it determines, following its inspection of a facility from an industry that it regulates, that the facility is violating some or other terms of the provisions of the FDA Act. The FDA Act is a legislation that gives the FDA the authority to carry out its inspections.
The issuance of an FDA Warning Letter is an indication that the facility is practicing some degree of nonconformity. A Warning Letter is among the FDA’s strongest tools of ensuring voluntary compliance from organizations with the provisions of the FDA Act.
The FDA publishes on its website any deviances of regulatory significance that it discovers from a facility during its investigations. In its viewpoint, a deviation of regulatory significance is one that leads to enforcement actions if the facility fails to carry out corrective action of whatever violations the FDA has documented.
Types of Warning Letters from the FDATo enable the public and concerned parties to view the Warning Letters it issues from time to time; the FDA has classified these on its website in the following manner:
A General Warning Letter is one that is issued to a company in whose activities the FDA notes significant variations from the principles laid out in the FDA Act. The Warning Letter carries a description of the variation or violation that the manufacturer has been practicing, along with a description of what actions needs to be taken to correct it.
Tobacco Retailer Warning Letters are those that are issued to manufacturers of products made out tobacco, such as cigarettes, smokeless cigarettes and related ones, who are found to be violating the provisions of the FDA’s Tobacco Control Act and with provisions of Title 21 of the Code of Federal Regulations, Part 1140 (21 C.F.R. Part 1140).
Drug Marketing and Advertising Warning Letters (and Untitled Letters to Pharmaceutical Companies) are those Warning Letters that the FDA website sorts out by month and consist only of Division of Drug Marketing and Communications and Drug Warning Letters. This kind of Warning Letter is issued to sellers of prescription drugs online when they are found to violate terms set out by the FDA.
Warning Letter closeout program
When the FDA issues a Warning Letter to a facility that comes under the various classifications; it follows up with it from time to time to ensure that the suggestions it advises are carried out. When the facility has carried out the necessary corrective actions; the FDA issues the Warning Letter Closeout, which closes the matter associated with the Warning Letter until the next FDA inspection.
Methods of issuing Warning LettersIt is only when it discovers violations that the FDA issues Warning Letters. It is through inspections that it discovers violations, from which Warning Letters follow. However, the FDA can also issue Warning Letters to facilities about which its receives complaints of wrongdoing from state personnel.
An FDA Warning Letter is not an enforcement action
In the perspective of the FDA; a Warning Letter is of an informal and advisory nature. An FDA Warning Letter is a description of the violation observed at a facility; but this in itself does not make the FDA take enforcement action. Rather, through a Warning Letter, the FDA advices the organization on what steps it has to take in order to rectify and correct the reasons for which the Warning Letter was issued. An FDA Warning Letter offers the organization enough opportunity to take corrective action that is of a voluntary and appropriate.
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