In a move that came as somewhat of a surprise given the Food and Drug Administration’s initial feelings on the matter, an advisory panel has recommended the approval of an anti-insomnia drug from Merck.  The panel convened yesterday let the FDA know that the drug known as suvorexant appears to be both effective and safe for patients.  They explained that doses recommended by Merck seemed appropriate and that insomnia sufferers appear to have been able to get sleep.  What’s interesting is that this runs somewhat counter to the FDA’s own findings.  Reports from earlier in the week suggested that the FDA was concerned about issues with extensive drowsiness after the effects of the drug were supposed to have worn off.  Also troubling the FDA were reports about the onset of suicidal thoughts.

Click here for more about the panel’s thoughts.

The Food and Drug Administration is currently in the midst of reviewing a drug from Merck that would be used for the treatment of insomnia.  Known as suvorexant, the drug has been shown in clinical trials to assist persons in falling asleep and then staying asleep once under, but those same trials have also illuminated a startling trend.  When the dosage is upped to 20 or 40 milligrams, drowsiness became a possibility the day after administration of the drug, and driving ability was also compromised.  Four females involved in the driving test had to actually cease driving in the middle of the test because they were so tired.  The FDA is also troubled by eight instances of patients experiencing thoughts of suicide.  An expert panel will advise the FDA tomorrow and a decision will follow after that.  It’s possible the FDA will want further study into the risks posed by low dosages.

For more information, follow this link.

In a new report, the Food and Drug Administration outlines the steps the organization has taken to regulate genetically engineered foods, or GE foods.  This type of food is differentiated from standard breeding and selection processes by the adoption of biotechnology.  The FDA notes that such foods entered our nation’s food supply in the 90s, with soybeans, cotton, and corn quickly becoming the most visible types of GE food.  The FDA requires that GE foods adhere to the same standards set forth in regards to any other type of food.  Manufacturers are also asked to work with the FDA prior to bringing a GE product to market.  At the moment, having a label disclosing the presence of GE ingredients is not required, but the FDA does encourage manufacturers to include such information voluntarily.

Click here for more about the FDA’s regulatory efforts.

The Food and Drug Administration has vowed to look more closely into the effects that large amounts of caffeine could have on children.  The move was prompted by the unfurling of Wrigley’s Alert Energy Gum, a type of gum that includes a decent dose of caffeine.  A Deputy Commissioner of the FDA explained that the current trend of food manufacturers adding caffeine to such products as jelly beans, chips, and more would have been unfathomable in the past.  As such, the FDA might be forced to revisit an issue that hasn’t really been considered since the 50s, when caffeine was approved for soda.  If the FDA decides that children could be negatively impacted by the proliferation of caffeine, they might take further action.

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A new report from the Food and Drug Administration details the research efforts of the Office of Minority Health.  It’s the office’s duty to make sure that the effect a given drug or medical product will have on minority populations is taken into account when the FDA is evaluating such items and formulating regulations.  For example, the OMH is using new methods of molecular blood typing to reduce the risks that crop up with the ongoing treatment of sickle cell disease, which requires multiple blood transfusions that can leave an individual sensitive to antigens and resistant to said transfusions.  The office is also seeking to use genetic testing to figure out what levels of warfarin would be safe for a patient, as well as a host of other issues.

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A reformulated version of Oxycontin aims to reduce the potential for abuse thanks to new properties that hinder nasal and injection-based usage, and the Food and Drug Administration has now approved labeling for the product that says as much.  Because of this, the original form of Oxycontin that did not have these abuse hindrances will be removed from the market.  Any generic forms of the drug based off of the original non-deterrent version of the medication will also no longer receive the approval of the organization.  That means that generics will now have to have the same abuse prevention mechanisms in place if they hope to reach the market.

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The Food and Drug Administration’s ability to regulate compounding pharmacies was recently called into question when a fungal meningitis outbreak stemming from contaminated steroid injections led to the deaths of 53 people and made 700 more ill.  Yesterday, the Commissioner of the FDA explained to lawmakers that inadequacies and conflicts in regulatory policy left the door open for this type of contamination incident.  She wants to see new laws put in place which give the FDA power to inspect and police compounders more strictly.  However, some lawmakers pointed to preexisting deficiencies in compounder regulation on the part of the FDA and wondered whether new laws would really be able to counteract those shortcomings.

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One would think that the Food and Drug Administration only approves drugs for use after they have weighed the results of all clinical trials conducted in regards to the medication.  But a new article shows that this isn’t always the case thanks to one big oversight:  when a trial has results that might be construed as negative, those carrying out the trial tend to hold that study back from publication.  As a result, only positive trials get widely reported, meaning that the FDA could have its hands somewhat tied by not being exposed to all available information.  An author describes how a campaign known as AllTrials seeks to change this potential publication bias by lobbying safety advocates and drugmakers alike to call for a change to the way things are done.  Two months ago, GlaxoSmithKline, a major drugmaker, signed a pledge to provide all trial data.

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Could heightened levels of arsenic be found in juices and rice cracker products in your home right now?  Consumer Reports and the Consumers Union branch of that organization are so concerned about such an occurrence that they have filed a Freedom of Information Act request to learn what the Food and Drug Administration turned up during its own testing of these products.  Consumer Reports noticed the potential for arsenic in rice products and juice more than a year ago, and prompted by their testing, the FDA vowed to conduct research of its own into the matter.  But since that time, the results of their studies have remained hidden from public view.  Consumer Reports hopes to change that.  They want to find out the results of as many as 1,300 rice product tests conducted by the FDA, and they also want to know the nature of an FDA proposal which might introduce guidelines for apple juice arsenic levels.

For more information, follow this link.

The Food and Drug Administration is being called upon by researchers and doctors to crack down on energy drinks and the labeling of such.  18 such individuals have sent the FDA a letter asking the agency to limit the level of caffeine that can be included in such products and force manufacturers to detail on the label how much caffeine resides inside.  They argue that makers of energy drinks have thus far not done a great enough job proving that their products are safe, especially for teenagers, who are largely thought to have a lower threshold for caffeine.  More than 20,000 people checked into an emergency room after suffering things like headaches or irregular heartbeats following the consumption of an energy drink in 2011.  The group behind the letter insists that energy drinks are largely marketed to the very teens who might be at risk.

For more information, follow this link.

An advisory panel to the Food and Drug Administration has voted not to recommend the approval of two drugs for the treatment of hot flashes in women going through menopause.  If approval is granted, gabapentin and paroxetine would become the first non-hormonal treatments for the condition ever approved.  Some doctors expressed concerns that a failure to approve the medications would result in women turning to unproven treatments and herbal supplements.  However, members of the panel explained that the side effects of the drugs far outweigh the benefits, as the medications barely outperformed placebos during a clinical trial.  The panel largely felt that this relatively low performance rate was not enough to approve items that could cause dizziness or suicidal thoughts.

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The Office of Inspector General under the Department of Health and Human Services has released a report looking at how closely drug manufacturers are meeting the terms imposed by the Food and Drug Administration in regards to high-risk medications.  The results are somewhat disconcerting.  Five years ago, the FDA passed a rule requiring new drugs to come out with plans dedicated to risk management.  But the report shows that numerous drug makers have neglected to provide all of the requisite information to the FDA.  This is a problem, as it could potentially endanger the health of patients.  For instance, doctors might not be fully informed of the risks posed by a certain drug to hit the market.  According to the report, 18 of 19 drug plans were apparently missing critical information or failing to hit their benchmarks.

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The Food and Drug Administration has acknowledged that local shortages of flu shots are a possibility but that stockpiles should be sufficient at this point that anyone in need of a vaccine will likely be able to get one without much trouble.  The FDA Commissioner has stated that it’s not too late to get a shot, and current production confirms this.  Seven manufacturers have been given the go-ahead to create shots for the illness, and an estimated 135 million products are thought to have been made at this time.  Of those, millions have not been administered and some still have to be shipped, so fret not.  Those having trouble finding a vaccine are being encouraged to visit flu.gov and enter in their zip code to find a provider near their home.

For more information, follow this link.

The Food and Drug Administration is celebrating the birthday of an item that we have grown used to since its inception:  the nutrition facts label.  The Nutrition Labeling and Education Act of 1990 paved the way for the label, but it wasn’t until January 6 of 1993 that the final ruling came out.  In the ensuing years, people have come to rely on this label to determine whether or not the food they consume is good for them.  In fact, the FDA conducted a survey in 2008 which discovered that 54% of respondents rely on the label information when making their food choices, which is up from 44% in 2002.  The FDA plans to pursue further changes to the nutrition facts label in the coming years based off of the latest scientific nutritional information and recommendations.

Click here for more about this history.

The Family Smoking Prevention and Tobacco Control Act passed in 2010 gave the Food and Drug Administration the power to exercise an option allowing the agency to enact greater controls on tobacco products.  Now, the FDA has given an indication that they might soon take advantage of those powers vested within them.  Their Regulatory Agenda for 2013 says they will propose new rules on tobacco products, a proposal that by law will likely have to be issued by April of this year.  There’s no word on what the rule might be, but once it’s issued, a comment period will be opened up to the public.  Right now, the FDA only enforces regulations pertaining to smokeless tobacco items, tobacco rolled by the user, and cigarettes.

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Genetically modified Salmon could soon be readily available all throughout the country, despite worries among some groups about the safety of such items.  The salmon is created through the introduction of two additional genes found in other types of fish.  The Food and Drug Administration has now ruled that this type of modification does not pose a safety issue to either the environment or consumer health.  The thought is that this type of salmon will be easier to harness for food due to the wider availability of such fish on land-based fish farms.  Detractors, however, believe this is a slippery slope that could lead to other genetically modified foods, and some worry the fish will be released into the wild.

For more information, follow this link.

Many recalls stem from the presence of an undeclared allergen in a food item.  To get a better handle on what might constitute an allergen threat to consumer health, the Food and Drug Administration wants to come up with so-called thresholds, basically what could constitute a hazardous level of a given allergen.  Up until February 7, anyone can submit their comments on this subject to the agency.  The FDA intends to figure out at what level could apparent allergens pose a serious risk, what allergens are most common, and how many people would be endangered by various allergens.  They hope that uncovered data will help them to introduce future rules pertaining to food safety.

For more information, follow this link.

Three members of the United States Congress are putting pressure on the Food and Drug Administration to crack down on haircare products which use formaldehyde in potentially dangerous levels.  The chemical is typically used in products that are designed to strengthen an individual’s hair.  In a letter to the FDA, the lawmakers explain that Brazilian Blowout usage has resulted in customers and stylists alike complaining about becoming ill.  This is allegedly due to the heightened amounts of the chemical in that particular product.  Even though the FDA warned the makers of the item over a year ago, the members of Congress allege that no further action has been taken since then.  They’re requesting further inquiry by the FDA on Brazilian Blowout and other items.

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For the first time ever, the Food and Drug Administration has acknowledged that there’s another food regulatory agency on par with what they themselves are able to accomplish.  By using something called the International Comparability Assessment Tool, the FDA was able to come to the conclusion that New Zealand’s food safety practices are at or near the same level as our own country’s.  The FDA and New Zealand thus entered into a systems recognition agreement.  It all comes about as part of the Food Safety Modernization Act.  The thought is that by recognizing low-risk countries for what they are, import safety can be better assured and the FDA can devote its limited resources to those areas that pose more of a threat to US consumer health.

Click here to learn more about the agreement.

The Food and Drug Administration is warning consumers about a scam in which a criminal might call an individual and attempt to convince the person that they are in fact an FDA official.  The scam targets persons who have unwittingly shopped at an unlicensed or otherwise fraudulent online pharmacy.  Once personal information has been given to such a website, the criminal then calls the targeted individual to tell them they have broken the law by going to that illegal pharmacy.  The scammer will then try to bully the person into paying a “fine” in order to avoid legal troubles.  The FDA tells consumers that they never engage in this type of practice, and a member of the School of Pharmacy at Virginia Commonwealth University further stresses that there are ways to ensure an online pharmacy is legitimate.

Click here for more about the scam.