Interesting Infographic on U.S. Dietary Supplement Consumption

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.

The Dietary Supplement Consumer: The 5 W’s answered about the more than two-thirds of U.S. adults taking dietary supplements, according to the most recent annual survey conducted by Ipsos Public Affairs on behalf of the Council for Responsible Nutrition (CRN).

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The FDA Safety and Innovation Act (FDASIA)

Research toolOn 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:

  • continued timely review of new prescription drugs,
  • increase the use of standardized electronic data in product submissions,
  • enhance communications with companies during drug development,
  • implement a structured benefit-risk framework in drug review,
  • put more focus on regulatory science, which seeks to create new tools, standards and approaches for use in assessing the safety, effectiveness, quality and performance of products, and
  • advance the development of drugs for rare diseases and encourage the development of biomarkers.

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:

  • Improved pre-submission process, which will allow industry request early FDA feedback on the appropriate  regulatory pathway to market through this enhanced pre-submission process.
  • Submission acceptance criteria, which will be used to evaluate submissions when they are received to ensure that FDA resources are focused on reviewing complete submissions.
  • Commitment to interactive and informal  communication between FDA staff and device applicants in order to collect appropriate additional information and meet review timelines.
  • Guidance document development and publication on FDA’s website to communicate the agency’s current  thinking on a topic.
  • Third-party review program intended to improve the efficiency and timeliness of the FDA’s review processes for specific types of devices.
  • A guidance, which focuses on factors to consider in the pre-market review process, including patient tolerance for risk, magnitude of the device’s benefit, and the availability of other  treatments or diagnostic tests.
  • Development of a transitional approach for the regulation of emerging diagnostics.

 

 

©Rachel Agheyisi, Report Content Writer, Regulatory Compliance Digest Blog

FDA’s Portal To India

SacksOfSpicesA 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

FDA's India Offices

Copyright © Rachel AgheyisiReport Content Writer, Regulatory Compliance Digest

Dangerous Supplement (Reumofan Plus) Now Sold as ‘WOW’

FDA Enforcement ReportIn 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:

  • Immediately consult a health care professional
  • Not to use any products with “Riger Naturals      S.A.” (the manufacturer of Reumofan Plus) printed on the bottom of      the bottle.
  • Report any health problems related to Reumofan Plus or WOW to FDA’s MedWatch Safety Information and Adverse Event Reporting  Program.

 

CLICK HERE for more information.

 

Copyright © Rachel Agheyisi, Report Content Writer, Regulatory Compliance Digest Blog

The FDA and Regulatory Science

 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: 

  1. Modernizing toxicology—the study of chemical, biological or physical agents that can be harmful—and improving the ability of tests, models and measurements to predict product safety issues. This includes, where feasible, the development of new methods that could reduce or replace animal testing.
  2. Crafting new tools and approaches for the development of personalized medicine; getting the right medicine to the right person at the right time.
  3. Supporting new and improved manufacturing methods by researching how new technologies affect product safety, effectiveness and quality.
  4. Ensuring that FDA is ready to evaluate innovative and emerging technologies with the necessary expertise and infrastructure.
  5. Expanding and improving FDA’s information technology infrastructure and the application of those resources to support sophisticated analyses of data.
  6. Implementing the prevention-focused food-safety system mandated by the Food Safety Modernization Act passed by Congress and signed into law by President Obama in January.
  7. Speeding the development of safe and effective medical countermeasures to protect against threats to U.S. health and security, such as chemical, biological, or nuclear threats or naturally occurring infectious disease outbreaks. Such countermeasures include drugs, vaccines, diagnostic tests and personal protective equipment.
  8. Developing a communications strategy that will help FDA adapt to rapidly evolving technologies that are changing how people receive and share information.

 Other major objectives of FDA’s regulatory science research include: 

  • The development of technologies to accelerate the large-scale manufacture of new influenza vaccines.
  • Creation and evaluation of rapid testing methods for the detection of infectious microorganisms in such biological products as blood and tissue.
  • Finding new methods to improve the shelf life and stability of products that have to be warehoused for use in an emergency.
  • Formulating new ways, such as needle-free systems, for more rapid use and self-administration of drugs. 

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: 

  • A clinical trial model was developed to help scientists quickly test the most promising drugs in development to treat women with rapidly growing breast cancers. The drugs are targeted to the biology of each woman’s tumor using specific genetic or biological markers.
  • By studying data from hundreds of clinical trials, FDA found that antidepressants can increase the risk of suicide in people under 25. This resulted in FDA placing warnings on the labeling and medication guides for these drugs. 
  • After the Deepwater Horizon disaster released in excess of 92 million gallons of oil into the Gulf of Mexico in 2010, FDA developed a more rapid, highly sensitive chemical testing method to ensure that seafood from the Gulf is safe for consumption. 

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

Read This If You Manufacture Medical Devices

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:

  1. Failure of the manufacturer to ensure that devices conform to defined user needs and intended uses and to include an adequate risk analysis in the design validation.  For example, the firm’s validation test model did not simulate for variety of sizes of human anatomy, including child-population and premature infants.
  2. Failure of the manufacturer to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a).  According to the warning letter, the firm did not provide documentation to demonstrate that all corrective actions were implemented following the initial violation notice.  Additionally, the firm did not include a plan and evidence of implementation of a systemic corrective action.

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