miércoles, 14 de marzo de 2018

FDA Patient Network News - March 14, 2018

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Medical Product Safety

Cantrell Drug Company: FDA seeks action to stop production and distribution of compounded drugs
FDA is alerting health care professionals and patients not to use drug products produced by Cantrell Drug Company of Little Rock, Arkansas, including opioid products and other drugs intended for sterile injection, that were produced by the company and distributed nationwide. The agency is concerned about serious deficiencies in Cantrell’s compounding operations, including its processes to ensure quality and sterility assurance that put patient safety at risk. Administration of contaminated or otherwise poor quality drug products can result in serious and life-threatening injury or death. See Cantrell article

Flu Products: FDA warns of fraudulent and unapproved flu products
As part of FDA’s ongoing efforts to protect consumers from health fraud, the agency is reminding consumers to be wary of unapproved products claiming to prevent, treat or cure influenza, or flu. This year’s severe flu season raises new concerns about the potential for consumers to be lured into buying unproven flu treatments, and even worse, buying counterfeit antivirals online from websites that appear to be legitimate online pharmacies. See Flu Products article

Kratom Powder: PDX Aromatics recalls Kratom Powder because of possible health risk
PDX Aromatics of Portland, Oregon DBA Kraken Kratom, Phytoextractum, and Soul Speciosa, has initiated a recall of certain kratom-containing powder products because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. See Kratom article


Medical Product Approval

FDA authorizes, with special controls, direct-to-consumer test that reports three mutations in the BRCA breast cancer genes
FDA has authorized the Personal Genome Service Genetic Health Risk (GHR) Report for BRCA1/BRCA2 (Selected Variants). It is the first direct-to-consumer (DTC) test to report on three specific BRCA1/BRCA2 breast cancer gene mutations that are most common in people of Ashkenazi (Eastern European) Jewish descent. These three mutations, however, are not the most common BRCA1/BRCA2 mutations in the general population. See BRCA article 

FDA approves new HIV treatment for patients who have limited treatment options
FDA has approved Trogarzo (ibalizumab-uiyk), a new type of antiretroviral medication for adult patients living with HIV who have tried multiple HIV medications in the past (heavily treatment-experienced) and whose HIV infections cannot be successfully treated with other currently available therapies (multidrug resistant HIV, or MDR HIV).Trogarzo is administered intravenously once every 14 days by a trained medical professional and used in combination with other antiretroviral medications.See HIV Treatment article


From the Commissioner

FDA Commissioner Scott Gottlieb, M.D., as prepared for oral testimony before the U.S. House Committee on Energy and Commerce Subcommittee on Oversight and Investigations hearing “Examining U.S. Public Health Preparedness for and Response Efforts to Seasonal Influenza.”
Thank you for the invitation to testify on our response to the 2017-2018 seasonal flu. This flu season has been particularly hard. I agree with my colleag
ues that investing in -- and working toward -- the universal flu vaccine is crucial. Unfortunately, given where we are today in the development process, that reality is still many years off.

While we should continue to focus on the discovery of a new breakthrough vaccine, we also must consider what immediate and intermediate steps we can take to enhance the production of existing licensed vaccines. And what should be done to invest in advanced domestic manufacturing to ensure new and existing technologies are scalable so that manufacturers can meet domestic and global demand.

There have been successes in developing alternatives to egg-based vaccines, such as cell-based and recombinant technologies, in part because of the collaborations and work by BARDA. However, despite these advances in vaccine development, the majority of manufacturers are continuing to produce egg-based vaccines. See Seasonal Influenza article

FDA efforts to help bolster U.S. shellfish market by taking mutually beneficial steps to resume shellfish trade with the EU
FDA announces proposed EU shellfish equivalence determination that imported molluscan shellfish from Europe is as safe as what we produce in the U.S. It will create new market access for U.S. exporters as well as make a wider selection of healthy and safe shellfish options available to consumers. See Shellfish Market article

FDA activities related to the ongoing post-market review of Essure and FDA’s commitment to keep women informed
Some of my most important time as Commissioner is spent speaking directly to patients and their families about significant health issues that affect their lives, from the devastating opioid crisis to the current flu season. Overseeing a wide array of medical products, the U.S. Food and Drug Administration plays a vital role in providing consumers with up-to-date, evidence-based information to help them make the most informed medical decisions. The products we regulate touch people’s lives in meaningful ways. See Essure article

FDA’s new efforts to advance implementation of the new consumer Nutrition Facts label for foods
Americans rely on the U.S. Food and Drug Administration to ensure that food labels contain updated nutritional information to help them make more informed food choices that lead to better health for themselves and their families. I’ve made nutrition one of my top priorities, and ensuring that consumers have accurate and science-based information concerning the link between diet and chronic diseases like diabetes, obesity and heart disease is part of that commitment. We need to advance new ways to use the science we’re learning about diet and nutrition as tools for reducing the burden of disease. Our update to the iconic Nutrition Facts label includes significant changes to help consumers make more informed dietary choices, and we are already seeing the new label on many products. See Nutrition Facts article

FDA’s commitment to modernizing food and nutrition programs
Americans rely on the U.S. Food and Drug Administration to make sure our food supply is the safest in the world. The FDA is responsible for helping oversee about 80 percent of the nation’s food supply. Making sure that we continue to modernize our food safety system and advance our work in the important area of nutrition is a high priority of mine. See Modernizing Food Programs article


Upcoming Public Meetings

Most FDA meetings are free to the public and do not require the public to register. Interested persons may present data, information, or views, orally at the meeting, or in writing, on issues pending before the committee. Other types of meetings listed may require prior registration and fees.

View FDA Patient Network Calendar of Sponsored Public Meetings for a list of meetings and workshops that may be of interest to patients and caregivers.


Opportunity to Comment

FDA rules have great impact on the nation’s health, these rules are formed with the public's help.  By law, anyone can participate in the rule-making process by commenting in writing.

View FDA Patient Network Opportunity to Comment on Current Draft Guidance page, for a list of current draft guidances and other topics of interest for patients and caregivers.


Drug Shortages

FDA knows the major public health consequences that can result from drug shortages. These shortages occur for many reasons including manufacturing and quality problems, delays and discontinuations. When issues are discovered, FDA works closely with the company to address risks involved to prevent harm to patients. FDA also considers the impact a shortage would have on patient care and access and works with the company to restore supplies while also ensuring safety for patients. The following list includes drugs currently in shortage, shortages recently resolved and drugs that have been discontinued.
More information on drug shortages and discontinuations: Drug Shortage Database and Vaccines, Blood, and Biologic Shortages.

FDA Announcements

FDA In Brief: FDA unveils research plan to inform policy, enforcement work related to prescription drug promotion
FDA has prioritized a robust social and behavioral science research program to help us understand how people make decisions about the products we regulate. This includes research surrounding how patients and health care providers understand prescription drug benefit and risk information in promotional materials. See Research Plan article  


Consumer Updates and Other Information

Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?)
Whether a product is a cosmetic or a drug under the law is determined by a product's intended use. Different laws and regulations apply to each type of product. Firms sometimes violate the law by marketing a cosmetic with a drug claim or by marketing a drug as if it were a cosmetic, without adhering to requirements for drugs. See Cosmetic article

Video: Dr. Richard Pazdur on Expanded Access
Learn about FDA's Expanded Access Program (also called Compassionate Use Program) from Dr. Pazdur, the Director of Oncology Center of Excellence. See Dr. Pazdur Video

Biosimilar Patient and Prescriber Outreach Materials
FDA offers a variety of patient and prescriber outreach materials, including graphics, drop-in content, and social media messages, to help promote understanding of biosimilars and interchangeable products. See Biosimilar article

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