The Food and Drug Administration has come out with a news release that seeks to explain their various efforts to help women understand how to maintain a healthy heart. In addition to making the general audience aware of the resources available, the agency is also explaining the important steps that can be taken to ensure safety.
First, those concerned about maintaining a healthy lifestyle are advised to check out the FDA’s “Heart Health for Women” website. The Office of Women’s Health Director extols the virtues of this site, citing its ability to help an individual drastically cut down on the risk of heart disease, which the National Heart, Lung, and Blood Institute estimates accounts for 25% of fatalities among females.
A cardiologist with the FDA explains the risks of heart disease tend to increase once a woman experiences menopause. This can typically be attributed to a decrease in estrogen levels. It should be noted, though, that hormone replacement is not recommended by the American Heart Association in order to mitigate the risks of heart disease.
To ensure your ongoing health, make sure to speak with a healthcare professional, especially if you suffer from diabetes or heightened cholesterol or blood pressure. Smokers should take pains to quit, and although taking a daily aspirin might be an option, you must speak with a doctor before doing so. Pay attention to food labeling, and learns the various signs that could be indicative of a heart attack so that you can react appropriately.
Safety advocates and lawmakers have grown concerned about a potential loophole in the law that leaves a grey zone in the regulation of compounding pharmacies. Last year, over 700 people became ill and 50 died because they were exposed to contaminated steroid injections from a compounder. To make sure such an incident never happens again, a bill was drafted that would bolster the Food and Drug Administration’s ability to oversee such institutions. Now, that measure has received the unanimous approval of the Senate Health, Education, Labor, and Pension Committee. As the bill currently stands, compounders would have to register and report adversity to the FDA. They would also be privy to inspections, the costs of which would be offset with a fee paid by the compounder itself.
For more about this initial approval, click here.
When an outbreak of a foodborne illness stemming from a manufacturing facility occurs, negligence to follow regulatory standards and simple error are typically to blame. But there are also some instances where a manufacturer refuses to acknowledge Food and Drug Administration warnings, or worse, employees knowingly endanger consumers.
The FDA has come out with a tool that aims to cut down on instances of the latter situation, willful contamination. Known as the Food Defense Plan Builder, the software program enables food manufacturers to put together plans which aim to identify shortcomings in the production process so that consumers can be protected.
By turning to the planner, those responsible for instituting safety measures at restaurants and manufacturing facilities are asked to answer questions about processing, packaging, and the food and the facility themselves. The planner will then put together an analysis of potential vulnerabilities and ways that those safety shortfalls could be combatted.
The FDA notes that purposeful contamination incidents are not all that typical, but when they do occur, the results can be catastrophic. In Texas back in 1996, a dozen workers were sickened because pastries they had consumed were infected with a certain Shigellabacteria. And a few years ago, employees with a bone to pick with a certain restaurant put pesticide into the salsa, leading 40 people to become sick.
Hopefully, manufacturers will take advantage of this important resource from the FDA.
A debate is still ongoing as to whether or not the Food and Drug Administration should be granted extended regulatory powers over compounding pharmacies. The issue was brought to the forefront after contaminated steroid injections from the New England Compounding Pharmacy led to a widespread outbreak that claimed the lives of more than 50 people and caused 700 to suffer an illness. The Senate Health, Education, Labor, and Pensions Committee looks to be largely in favor of the creation of a new “compounding” category that would be subject to FDA regulations. However, the bill does not curry the same kind of support in the House, where lawmakers are more divided on the issue. Nevertheless, state regulators and the FDA alike have spoken about the need for such a law.
Click here for more about the bill.
The Food and Drug Administration has grown increasingly concerned about the prevalence of bacteria that is resistant to antibiotics. Although antibiotics are certainly a valid treatment option when dealing with infectious organisms, over the course of time, certain organisms have developed a resistance to the very drugs meant to fight them.
In a new report, two members of the FDA explain the organization’s efforts to protect consumers from this threat. It starts with ensuring that livestock are only provided with antibiotics for the treatment of sickness as opposed to administration for the purpose of fostering growth. When we eat livestock that has been given a steady stream of antibiotics, the worry is that we ourselves will be more susceptible to antibiotic-resistant organisms.
Consumers can also take steps to protect themselves from these types of bacteria. For one thing, you can be more discerning when it comes to the taking of antibiotics. If you suffer from a simple cough or even a minor case of the flu, don’t push your doctor to provide you with antibiotics. Not only will this not really treat the illness itself, but it could lead to the development of resistant organisms.
You can also take steps to limit your exposure to bacteria altogether. Cook your food all the way through and keep kitchen surfaces clean so that bacteria can’t fester and spread.
In a new report, the Food and Drug Administration explains how the agency is attempting to bolster the efficacy of clinical trials by pushing for more minorities to be involved with said trials.
Getting people of varying backgrounds and ethnicities into these trials is vital for drug makers looking to exhibit the safety and effectiveness of a product. Without adequate representation, reactions that would affect a given demographic might not be properly demonstrated in trials as they should.
Genetics can play a critical role in how a person reacts to a drug and how susceptible an individual is to certain maladies. The Office of Minority Health’s director explains that Hispanic individuals and African Americans are more at risk of things like obesity, heart disease, HIV, and diabetes. Differences in genetic coding can also cause cancer treatment to be more toxic and blood pressure drugs and antidepressants to be less effective.
But despite these differences, underrepresentation is common. Hispanics stand at around 16% of the country’s population yet only make up 1% of persons in clinical trials. African Americans, which make up 12% of U.S. citizens, only make up 5% of trial participants.
The FDA Safety and Innovation Act from last year paves the way for efforts that can get minorities more involved in clinical trials so that demographic-specific issues might be addressed. By July of this year, the FDA is tasked with reporting on current trends in order to improve representation in trials. Until then, the agency advises that persons interested in clinical trials ask their doctors about availability.
A Food and Drug Administration news release explains the agency’s efforts to reduce the threat of polio around the world. Although vaccines have pretty much eliminated the disease from America, that isn’t the case in the rest of the world, where certain countries are still privy to the disease. Kids under five are particularly at risk. To combat the threat, the FDA has been teaming with the World Health Organization since 1988, an effort that has reduced polio drastically. Last year found 223 people contracting polio, compared with 350,000 less than 25 years prior. But complete eradication remains just out of reach, which is why the FDA is looking into the adoption of new types of vaccines that that don’t carry the risk of mutating into a virus.
For more information, follow this link.
As society becomes more and more globalized, the Food and Drug Administration is turning its eye toward improving the safety of drugs and food products all around the world. In a new report, the agency describes how they’re taking a device readily available in the United States and using it to keep citizens in Southeast Asia and Sub-Saharan Africa safe from counterfeit malaria medications.
The pilot program will start in Ghana because of its flourishing pharmaceutical industry and stable government. The movement was deemed necessary because of findings which show that a full 33% of malaria drugs in the aforementioned regions are either fake or aren’t up to par with actual medication. This issue is particularly serious when you consider that 660,000 people, most of them kids, die around the world every year because of malaria.
The FDA hopes to protect people via the deployment of the Counterfeit Detector Device, or CD-3. The item was actually the brainchild of a member of the Forensic Chemistry Center of the FDA. Using ultraviolet lights, the product can pick up on signatures which, when placed next to an authentic version of the item, demonstrate a fraud. Mail hubs and ports in America already utilize these devices to determine whether an Internet-purchased product from overseas is on the level.
The tools will be made available to five Ghana sites, as will training and the resources necessary to carry out proper testing of products from nearby medical facilities.
The Food and Drug Administration, in its ongoing quest to protect citizens and educate patients on safety matters, has just launched a website for the FDA Patient Network. Those interested in learning more about medical devices and medications are encouraged to visit.
The FDA Patient Network was ostensibly started in 2011 when Patient Network News was launched, but the FDA’s efforts in the patient outreach arena actually have their genesis back in the 1980s, when the agency worked with patient advocates during the AIDS crisis. Since then, the FDA has strived to get the opinions of patient groups whenever new regulations are being considered.
Last year’s FDA Safety and Innovation Act sought to further expand the partnership between the public and the FDA to improve the regulatory process, and the Patient Network makes that partnership official. In addition to the aforementioned newsletter and website, the FDA will hold its second ever Patient Network meeting this summer. Attendees can expect to learn more about how the FDA oversees medical products from development to post-market regulation.
The new website, though, could be the real standout of these patient safety awareness efforts. By visiting, patients can gain insights into how the FDA works as well as learn about various diseases, medications, and treatment options. Those interested in clinical trials can even learn about such events.
As well as helping citizens stay informed on matters of such consequence, the FDA hopes to use the concerns of patients to improve their own abilities and knowledge base.
In the past few weeks, compounders have been recalling sterile products in droves over concerns that said sterility cannot be assured. Many of those recalls have stemmed from inspections by the Food and Drug Administration that uncovered the types of conditions that could lead to contamination.
Nevertheless, the Commissioner of the FDA feels that current laws leave the agency at a disadvantage when it comes to policing such compounders. She said as much during questioning yesterday by the House Energy and Commerce Subcommittee on Oversight and Investigations.
Members of that committee lobbed questions the Commissioner’s way in regards to how the organization handled a variety of complaints made about the Massachusetts-based New England Compounding Center. That company had made available certain steroid injection products that were reportedly contaminated with fungus. 730 people sustained a fungal meningitis infection, and 51 persons are thought to have died because of the illness.
The Commissioner expressed disappointment over the fact that the agency did not more aggressively go after compounders like the NECC, and she has asked for alterations to the law which could improve the FDA’s oversight of such facilities. At the moment, she believes the FDA’s hands are tied thanks to conflicting laws that allow compounders to dispute inspection access.
Recently, the FDA has handed out inspection reports to 31 different compounders, and a variety of recalls have been issued. Some lawmakers believe this shows the FDA already has the power to police the compounders.