I like graphics that are based on reliable data, which is why I am sharing this one that gives an informative snapshot of dietary supplement consumers in the U.S.
Infographic from Council for Responsible Nutrition. See www.crnusa.org/consumersurvey for more.
Filed under: Select US Regulatory Initiatives | Tagged: dietary supplements | Leave a comment »
On July 9 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA) became law in the U.S. Why is this important? It is important because the law reauthorizes and extends the U.S. FDA’s authority to collect user fees from industry to fund reviews of innovator drugs, medical devices, generic drugs and bio-similar biologics.
This article summarizes some of the provisions of the new law and the implications of user fees the drug development process.
The Provisions of FDASIA
As part of its regulatory responsibilities, FDA receives thousands of applications for potentially promising medical products every year. The task of reviewing these submissions falls on a large team of FDA experts, including doctors, chemists, bioengineers, and statisticians who must determine, in a timely manner, whether a proposed new product is safe and effective for patients.
The FDASIA is the fifth authorization of the Prescription Drug User Fee Act (PDUFA), which was first enacted in 1992, and the third authorization of the Medical Device User Fee Act (MDUFA), which was first enacted in 2002. CLICK HERE for details of the reauthorizations of the PDUFA and MDUFA.
According to FDA Commissioner, Margaret Hamburg, it takes steady and reliable funding provided by user fee programs such as the PDUFA and MDUFA, to maintain and support the work of this pool of experts. She views the authorization of user fee collection as a testament to the important role FDA plays daily in America’s public health, innovation, and commerce.
FDASIA also provides for two new user fee programs for generic drugs and bio-similar biologics build on the successes of these two established user fee programs. The Generic Drug User Fee Act (GDUFA) will support FDA generic drug review, in particular, address the backlog caused by increased generic drug applications, their growing complexity, and the number of generic drug facilities now located overseas. CLICK HERE for additional information on the GDUFA.
The second new user fee program, the Bio-similar User Fee Act (BsUFA), will collect fees for products under development shown to be “bio-similar to” or “interchangeable with” an innovator FDA-licensed biological product. CLICK HERE for more information about the BsUFA.
Other provisions of the FDASIA will ensure that the FDA is equipped with new tools to better combat drug shortages, ensure the safety and security of the drug supply chain and encourage drug innovation.
Some Specifics of the User Fees
Under PDUFA V, fees paid by industry will support the following:
The MDUFA III represents a commitment between the U.S. medical device industry and the FDA to increase the efficiency of regulatory processes in order to reduce the time it takes to bring safe and effective medical devices to the U.S. market. Specifically, in exchange for the user fees paid by industry, MDUFA III includes specific provisions for:
©Rachel Agheyisi, Report Content Writer, Regulatory Compliance Digest Blog
Filed under: FDA, PDUFA and MDUFA | Tagged: Bio-similar User Fee Act, BsUFA, drug development, FDA, FDASIA, GDUFA, Generic Drug User Fee Act, MDUFA, Medical Device User Fee Act, PDUFA, Prescription Drug User Fee Act | Leave a comment »
A cursory look in our kitchens confirms the fact that it is indeed a small world after all. Those of us living in the U.S. take know that as part of our daily routines, including the foods we consume. India is a case in point.
According to the U.S. Commerce Department, nearly one quarter of the spices, oils and food colorings used in the U.S. comes from India. Overall, in 2011, India was the second largest drug exporter and the seventh largest food exporter to the U.S.
It makes sense then that a high-level U.S. agency plays a prominent role in coordinating the interests of Americans in this ever-expanding global village. As part of its broader regulatory functions, the U.S. Food and Drug Administration (FDA) works to ensure that foreign-produced foods and drugs are safe, effective and of good quality.
FDA Collaboration with India
As part of its response to globalization, FDA formulated a global strategy to increase its regulatory role in the international public health community. One component of that strategy includes opening FDA posts overseas in key areas such as China, India, the Middle East, Europe, and Latin America. These posts help FDA build strong relationships with officials overseas and see first-hand how foreign-based facilities operate.
With respect to India, FDA now has offices in New Delhi and Mumbai staffed by technical experts and experienced investigators in food and medical products. The local presence allows FDA to maintain close contact with India’s government, industries, trade associations, and scientific and academic communities.
According to Bruce Ross, FDA’s country director based in the New Delhi office FDA’s India offices act as the portal through which information on food and drug safety flows back and forth among FDA, the Indian government and industry. Ross notes that the relationship is essential when new regulatory requirements come along, including those that are part of the Food Safety and Modernization Act (FSMA), currently being implemented by FDA. FSMA requires importers to be responsible for ensuring that foreign suppliers have adequate controls to produce safe food.
The Benefits of Collaboration
One area where collaboration pays off is in the tracking and reporting of product contamination and dangerous outbreaks. FDA credits its local presence with the successful tracking of the source of a Salmonella outbreak in the U.S. in March 2012. When the source was linked to a manufacturer in India, two FDA food investigators from the Mumbai office were dispatched to the facility. After FDA’s inspection verified that the tuna product implicated in the outbreak came from the suspect facility and uncovered potential sources of contamination, the Indian government pulled the manufacturer’s license.
Another area where collaboration pays off is in the provision of industry-related training. According to Ross, FDA responds to requests from the Indian government to train representatives from industry, agriculture and commerce in agricultural and manufacturing standards and practices used in the U.S. Such training provides a proactive way of ensuring that products imported to the U.S. are safe and meet the requisite standards for quality.
For example, in September 2012, experts from FDA’s Center for Food Safety and Applied Nutrition (CFSAN) partnered with the Joint Institute for Food Safety and Applied Nutrition (JIFSAN) and the Indian Spices Board to present a week-long training program in Cochin, India. JIFSAN is administered by FDA and the University of Maryland. More than 70 participants from India’s government, industry, universities and trade groups gathered to learn about effective methods for ensuring food safety for spices and botanicals (plant parts and extracts).
CLICK HERE for more information
Copyright © Rachel Agheyisi, Report Content Writer, Regulatory Compliance Digest
Filed under: Compliance Resources, Consumer Protection Alerts, FDA | Tagged: Center for Food Safety and Applied Nutrition, FDA' global strategy, Food and Drug Administration, food safety, Food Safety and Modernization Act (FSMA), Food Safety Modernization Act | 1 Comment »
In December 2012, the Food and Drug Administration (FDA) send out a notice warning the U.S. public that a product distributed and sold under the name ‘WOW’ is a disguise for another product one that can cause serious harm.
FDA had sent two prior warnings in 2012 warning the public that Reumofan Plus — marketed as a natural dietary supplement for the treatment of various conditions, including arthritis and bone cancer– contains undeclared active ingredients found in prescription drugs that should only be used under the supervision of a health care professional.
Since June 2012, FDA has received reports of serious, and sometimes fatal, outcomes from consumers who used Reumofan Plus. The reports include liver injury, severe bleeding, corticosteroid withdrawal syndrome, adrenal suppression and stroke. In addition to causing injury on their own, the hidden drugs found in these products could interact with other medications, resulting in serious health consequences.
According to Brad Pace, regulatory counsel at FDA’s Health Fraud and Consumer Outreach Branch, some distributors have deliberately put a new label and a new name, WOW, on bottles of Reumofan Plus to sell remaining supplies deceptively.
FDA suggests that consumers who have taken this supplement take the following actions:
CLICK HERE for more information.
Copyright © Rachel Agheyisi, Report Content Writer, Regulatory Compliance Digest Blog
Filed under: Consumer Protection Alerts, FDA, FDA Warning Letters | Tagged: bad drugs, Dietary supplement, FDA product warnings, Food and Drug Administration, MedWatch, Reumofan Plus, unsafe drug products | 1 Comment »
What is regulatory science?
According to the U.S. Food and Drug Administration (FDA), regulatory science is the science of developing new tools, standards and approaches to assess the safety, effectiveness, quality and performance of FDA-regulated products.
As noted in an earlier article, the FDA has extensive regulatory oversight that covers medicines, medical devices, and foods consumed in the U.S.
According to practitioners, there is a growing gap between research/discovery and the delivery of products to consumers, which regulatory science will help bridge. The idea being that as new discoveries yield increasingly complex products, the FDA must be able to make science-based decisions that result in sound regulatory policy. By providing a strong scientific foundation, it is hoped that the agency will be able to fulfill its functions better and faster while safeguarding the health of American consumers.
What are the components of FDA regulatory science?
In August 2011, FDA released its Strategic Plan for Regulatory Science, an initiative that identifies eight priority areas essential to the continued success of FDA’s public health and regulatory mission. The plan is focuses on the following target areas:
Other major objectives of FDA’s regulatory science research include:
Why should we care about regulatory science?
We should care because how well the FDA does its job affects significant aspects of our lives, such as the drugs we take, the safety of the foods we eat, and how quickly they are developed and delivered to us.
Even though it is still early in its implementation, a number of success stories are already attributed to the FDA regulatory science plan. Examples include:
We will keep track of future developments.
CLICK HERE to for highlights of the FDA strategic plan document.
If you would like a full copy of the plan document, go here.
© Rachel Agheyisi, Report Content Writer, Regulatory Compliance Digest
Filed under: Consumer Protection Alerts, FDA, US Regulatory Agencies | Tagged: Drug approvals, drug safety, drug testing, FDA, FDA regulatory oversight, FDA strategic plan for regulatory science, food safety, medical devices, regulatory science | Leave a comment »
If you’ve read some of the other articles posted here, you’re probably aware that the U.S. Food and Drug Administration (FDA) has legal authority to regulate a variety of products manufactured and sold in the U.S. Among them are medical devices. The FDA has responsibility to provide premarket approval for new devices, as well as regulate the manufacturing and performance standards. Additionally, the agency tracks reports of device malfunction and serious adverse reactions. As with the other products under its jurisdiction (such as biologics, drugs, cosmetics) the FDA conducts inspections of facilities engaged in the manufacture of medical devices.
Sometimes, those inspections reveal non-compliance of varying degrees, which require appropriate remediation on the part of the alleged violators. A warning letter from the FDA spells out the details of the violation and the required corrective actions.
Such was the case with the agency’s recent inspection of a California-based medical device manufacturing facility. According to the warning letter issued to the manufacturer by the FDA’s San Francisco District, the agency indicated that its inspection revealed that the firm’s devices are adulterated, in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements (as required by Title 21, Code of Federal Regulations (CFR), Part 820).
Although the manufacturer had responded to the initial notice of violation, the FDA considered the response inadequate. What were the violations identified during the FDA’s inspections? According to the warning letter, they included the following:
The medical device manufacturer was given fifteen business days to inform the FDA, in writing, of the specific steps it had taken to correct the noted violations, as well as an explanation of how it plans to prevent these violations, or similar violations, from occurring in the future.
The warning letter also included the possible consequences of failure to comply promptly. Failure to correct the violations within the specified period may result in regulatory action by the FDA without further notice. The regulatory actions include seizure, injunction, and civil money penalties. Additionally, premarket approval applications for the related Class Ill devices will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected. Federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts.
In short, failure to fix the noted violations may result in significant business costs.
CLICK HERE to read the full copy of the warning letter.
Copyright Rachel Agheyisi, Report Content Writer, and Regulatory Compliance Digest Blog
Filed under: Enforcement Updates, FDA, FDA Warning Letters | Tagged: 21 CFR, current good manufacturing practices, FDA, FDA Warning Letter, Food and Drug Administration, medical devices, premarket approval | 1 Comment »
Product safety has gone global. It is one of the byproducts of our growing global village. Despite the volume and variety of domestically produced products, U.S. consumers continue to show increasing demand for imported goods of all kinds. Since the U.S. Food and Drug Administration (FDA) has responsibility for ensuring the safety of most of the products Americans consume, the agency’s work has gone global. It is an expanding regulatory frontier.
In April 2012, FDA published a report, which documents how the agency works (through overseas inspections and collaborations with foreign governments) to ensure that the imported foods, medical products, and other goods it regulates meet the same high standards for safety and quality set for products manufactured domestically. One major area involves medical products.
The Global Drugstore
According to FDA, 40% of drugs (generic and prescription) consumed in the U.S. are manufactured outside of the U.S. Few countries, if any, have the same regulatory controls (including clinical review process, manufacturing and quality standards) that the FDA requires of U.S.-based manufacturers of the food and medical products it regulates.
Globalization of the medical product industry presents regulatory challenges from product development to final use by the consumer. For example,
A Global Strategy
Recognizing the fact that globalization is not a transitory phenomenon, FDA has formulated a global strategy to increase its regulatory role in the international public health community. Some of the components of that strategy include:
CLICK HERE for a copy of the bulletin that summarizes the report.
GO HERE to get a full copy of the entire Global Engagement report.
Copyright Rachel Agheyisi, Report Content Writer, and Regulatory Compliance Digest Blog
Filed under: Compliance Enforcement Activities, Consumer Protection Alerts, FDA | Tagged: FDA, Food & Drug Administration, global engagement, global health, product quality standards, product safety, public health | 1 Comment »
As we presented in an earlier article on this blog, the U.S. Food and Drug Administration (FDA) has legal authority covering products such as biologics, drugs, foods, veterinary products, cosmetics, and medical devices. The FDA’s Office of Regulatory Affairs (ORA) leads the agency’s field activities relating to inspections and enforcement. It is, therefore, important for manufacturers to be current on all legal requirements for regulated products. It makes business sense because knowledge is critical for compliance, risk management, and avoidance of non-compliance costs.
However, it appears some manufacturers assume they can operate under the FDA radar and get away with some unapproved products, manufacturing practices, and product claims. Perhaps they will be successful in the short term, but in the age of Internet marketing and aggressive enforcement activity, non-compliant operators will ultimately be spotted and “tagged”.
Such is the case of a Kentucky-based firm, which manufactures and distributes products for animal consumption. The firm recently received a warning letter from the FDA’s Cincinnati District Office. According to the letter, the agency reviewed the claims included in the labeling of the firm’s products, and deemed them non-compliant.
What is noteworthy is the fact that the FDA inspection/review included the claims made on the manufacturer’s website where the products are available for sale! The product claims indicated that the products in question are intended for use in the mitigation, treatment, or prevention of disease in animals. The FDA associates such claims with drugs, which would make the manufacturers’ products new drugs. The problem is that the products had not received prior FDA approval as new animal drugs. Consequently marketing them violates the Federal Food, Drug, and Cosmetic Act (the umbrella Act for the FDA’s legal authority).
The warning letter indicated that the manufacturer‘s earlier corrective action failed to implement the post-inspection changes requested by the FDA. It reiterated the manufacturer’s responsibility for ensuring that all of its products comply with the Act.
The company was given 15 working days of the receipt of the warning letter to bring its products into compliance with the law, including a review of its websites, product labels, and promotional materials. Failure to correct the violations promptly may result in enforcement action without further notice from FDA. Enforcement action may include, but is not limited to seizure of violative products and/or injunction against the manufacturers and distributors of violative products.
The bottom line is that non-compliance is disruptive and potentially costly financially and in terms of negative impact on business reputation. Non-compliance risks and costs are easy to avoid with a little due diligence.
CLICK HERE for a full copy of the FDA’s warning letter to the product manufacturer.
Copyright Rachel Agheyisi, Report Content Writer, and Regulatory Compliance Digest Blog
Filed under: Enforcement Updates, FDA, FDA Warning Letters | Tagged: FDA, FDA product warnings, FDA Warning Letter, Food and Drug Administration, Title 21 of the Code of Federal Regulations, unsafe drug products | Leave a comment »
It has been a while since I reported on warning letters issued by the U.S. Food and Drug Administration (FDA) as part of its inspection, compliance, enforcement and criminal investigation activities. Well this post shows that the FDA continues to put violators on notice.
As described in a previous article on this blog, FDA warning letters fall into three broad categories depending on the nature of the violation and the corrective action required. For example, when the FDA finds that a manufacturer has significantly violated FDA regulations, the agency notifies the manufacturer in the form of a general warning letter. A general warning letter identifies the violation, such as poor manufacturing practices, problems with product claims, or incorrect directions for use of a product and the specific corrective actions necessary within a timeframe. The FDA may issue a close-out letter once the agency has completed an evaluation of the corrective actions undertaken by a firm in response to a warning letter.
This article describes one such general warning letter issued recently to a Pennsylvania-based dietary supplement manufacturer by the FDA’s Philadelphia District. According to the letter, FDA inspectors found a number of significant violations of the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements (CFR, Title 21, Part 111).
Specifically, the CGMP violations, which cause the dietary supplement products to be adulterated, include the following:
The dietary supplement manufacturer was given 15 days to notify the FDA in writing of the specific steps it had taken to correct the violations and to ensure that similar violations do not occur in the future.
CLICK HERE for a copy of the FDA warning letter.
Copyright Rachel Agheyisi, Report Content Writer, and Regulatory Compliance Digest Blog
Filed under: Compliance Enforcement Activities, Enforcement Updates, FDA, FDA Warning Letters | Tagged: cGMPS, FDA product warnings, FDA Warning Letter, Food and Drug Administration, unsafe drug products | 1 Comment »
This just out:
The First National Medicare-Medicaid Payment Incentives and Penalties Summit, www.MedicareMedicaidPaymentSummit.com, will be held on May 30 – June 1, 2012 at the Hyatt Regency Crystal City in Washington, DC.
What it is and how to participate:
For more information on registration, conference speakers, and topics, go to www.MedicareMedicaidPaymentSummit.com.
Filed under: Compliance Resources, The US Health Care System | Tagged: Centers for Medicare & Medicaid Services, Medicaid, Medicare, National Medicare-Meicaid Summit | Leave a comment »
FDA Enforcement Reports
Regulatory Compliance Digest 