FDA Archives - Blizzard Greenberg PLLC

FDA Sends Far Fewer Advertising Letters in 2017

January 2, 2018/in Dangerous Drugs /by e.blizzard

The U.S. Food and Drug Administration (FDA) is responsible for policing all prescription and over the counter medications and medical devices. The agency ensures devices and drugs comply with mandated safety standards and ensures manufacturers abide by advertising rules. Unfortunately, the FDA sent far fewer advertising letters out this past year.

In 2017, the FDA only sent out three warning letters for advertising violations compared to 11 in 2016. While some might believe the decrease is caused by better adherence to guidelines, this isn’t entirely true. Advertising regulations are meant to protect consumers from false claims made by drug and device manufacturers, and without strict policing of violators, consumers can easily be duped.

One of the warning letters the FDA sent out for advertising violations was for false and misleading information included in promotional materials for the insomnia drug Zolpimist. Promotional materials must be sent to the FDA for approval before use, but certain materials including a webpage did not receive approval. The other two warning letters addressed false and misleading claims from the manufacturers of the opioid ConZip and the weight loss drug Contrave.

False or Misleading Claims

Most advertising violations are for false or misleading claims. For the FDA, this can mean manufacturers minimized risks in advertisements, presented information or data that is untrue, or failed to include important information regarding the drug or device. Manufacturers must always include risk information on all advertising materials so physicians and consumers can make informed decisions about using a drug or device use. Without including the appropriate risk information, many consumers could end up taking medications and suffering serious side effects they knew nothing about.

All patients have a right to know the risks associated with medications and devices. Unfortunately, not all manufacturers express these risks and abide by advertising rules and the FDA only catches some of the violators.

FDA Paves The Way For More Drug Inspections Overseas

December 4, 2017/in Dangerous Drugs /by e.blizzard

There is a fine balance between providing lifesaving medicine to the public and protecting the public from potentially harmful medicine. This is the line the U.S. Food and Drug Administration (FDA) must walk as it regulates drugs and medical devices. However the agency is making tremendous strides in patient safety by allowing more drug inspections in manufacturing facilities overseas.

The FDA recently announced it is taking steps toward the implementation of the amended Pharmaceutical Annex to the 1998 U.S.-European Union (EU) Mutual Recognition Agreement (MRA). This agreement allows regulators from both countries to use each other’s inspections of pharmaceutical manufacturing facilities to ensure they are meeting the appropriate health and safety standards. The FDA will now recognize the authority of drug regulatory agencies in Austria, Croatia, France, Italy, Malta, Spain, Sweden, and the United Kingdom to inspect facilities to see if they meet with FDA requirements.

This will have a huge impact on the availability of new medicines, as many medicines approved by the FDA are partially or completely manufactured overseas. Before recognizing these drug authorities, the FDA alone was responsible for overseas inspections. However, with massive numbers of drug companies and facilities, overseeing them all was a difficult task for the FDA.

The partnership prevents duplication of facility inspections, allowing more resources to be devoted to countries and facilities where there may be a greater risk of substandard manufacturing practices. By partnering with other countries, more facilities are inspected more often to ensure they are using good manufacturing processes.

Unfortunately, these overseas strides only seek to remedy a small part of what medications and devices can do to harm patients. Sometimes drugs meeting the FDA’s manufacturing requirements still cause significant injuries to patients. Oftentimes dangerous side effects are only discovered after a drug has hit the market. Drugs like anti-nausea medications and heartburn relievers can cause permanent injuries to unknowing patients.

What Patients Can Do

All medications and medical devices come with risks. However, patients have a right to know all of these risks upfront, so they can make informed decisions about their care. The FDA releases warning letters to the public when a manufacturer fails to meet FDA standards, including manufacturing standards and/or safety standards. Patients can look up the compliance history of any drug, manufacturer, or facility on the FDA’s website. By investigating the history of a drug or device, patients can make better informed decisions about their healthcare.

One-Third of All FDA Approved Medications Pose Safety Risks

May 30, 2017/in Dangerous Drugs /by e.blizzard

As patients, we expect the prescriptions our doctors give us to be safe to take. However, a recent study found this might not be the case. Researchers determined one out of every three medications poses additional safety risks after approval from the U.S. Food and Drug Administration (FDA).

The study, published in the Journal of the American Medical Association (JAMA), looked at 222 separate medications approved by the FDA between 2001 and 2010 and tracked them through February 2017. Researchers discovered the FDA took some kind of action on nearly 32% of the medications.

Three of the tracked medications were completely removed from the market and 61 were given black box warnings, the most severe warning issued by the FDA. Unfortunately for patients, the average amount of time it took for the FDA to take action on a medication was 4.2 years.

Patients Facing Increasing Drug Dangers

The high number of medications posing additional safety risks coupled with the length of time the FDA takes to issue warnings, leaves patients facing increasing dangers from prescription drugs. One of the reasons behind increasing drug dangers is that drug companies often use very small samples of patients and many of their drug studies only last six months or less.

Because drug manufacturers produce insufficient clinical data, the true effects of their products are not known until long after they are released onto the market. The increasing dangers of prescriptions drugs put patients in a tough position.

Know Your Rights

Drug manufacturers are required to warn both patients and doctors of the risks associated with their products. This allows patients and doctors to make informed decisions about their care. When a pharmaceutical company harms patients through failing to warn of risks, improper labeling, inadequate testing, or other negligent actions, it can be held legally responsible for the resulting damages.

Will New FDA Bill Help Or Hurt Americans Seeking Cures?

May 18, 2016/in Dangerous Drugs /by e.blizzard

The Senate’s Committee on Health, Education, Labor, and Pensions is currently reviewing a new Bill that would open up eligibility for FDA priority review for all medical devices. The Advancing Breakthrough Devices for Patients Act is trying to make quality medical devices more readily accessible for doctors and patients, but opponents of the Bill worry that it will increase the likelihood of defective medical devices hitting the market and harming patients.

Currently, the FDA only grants priority review status to the medical devices that pose the highest risks, called Class III devices. However, the legislation would open up expedited approval possibilities for all medical devices.

How Do Medical Devices Get Priority Review?

Device manufacturers submit applications to the FDA to receive priority review that will reduce the amount of time the FDA takes to make a determination on the safety of a device by allocating attention and resources to the evaluation of the application. The FDA grants priority review to devices that would significantly improve the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions compared to the standard treatment options currently available.

Defective Medical Devices

While speeding up the availability of new medical devices may sound like an improvement, if these devices are not rigorously studied before being used in or on patients’ bodies, defective devices could easily be approved.

Medical devices like DePuy Hip Implants, IVC Filters, and Power Morcellators were widely used by physicians, but have since been discovered to cause serious and life-threatening complications.

Device manufacturers have a duty to thoroughly test their mechanisms and to produce safe products for consumers. When large companies fail to uphold these standards, they put patient’s lives at risk.

The FDA’s Approach To Speeding Up Medication Availability

March 30, 2016/in Dangerous Drugs /by e.blizzard

The Food and Drug Administration (FDA) has a detailed process for approving medications and medical devices. Sometimes the process is sped up for medications or cures that are the first of their kind or substantially better than currently available medications. Neither all medications nor all medical devices go through the same expedited approval process.

The FDA has four methods of making medications available as quickly as possible. Based upon consideration of various circumstances, a medication will be assigned to the appropriate process.

The Fast Track process is designed for medications that treat serious medical conditions that currently have an unmet medical need. While what is considered a serious medical condition is a matter of judgment, some conditions includes AIDS, Alzheimer’s, heart failure, cancer, epilepsy, depression, and diabetes, among others. The manufacturer must request Fast Track designation, but the request can be initiated at any stage during the FDA approval process.

Breakthrough Therapy is used for any medications that demonstrate via clinical trials that they will provide a substantial improvement over available treatment options. The manufacturer must request breakthrough therapy before the end of the second phase of its clinical trials.

Accelerated Approval allows medications for serious conditions that can fill an unmet medical need to be approved based on a surrogate endpoint, or a marker that can indicate the clinical benefit of a drug. Accelerated approval was created because it can take many years to understand whether a medication successfully treats a condition, and accelerated approval can save valuable time in the approval process. The manufacturer is required to continue to conduct studies to confirm the drug’s benefit. The FDA can withdraw the approval if the studies fail to prove any benefit.

Priority Review designation commits the FDA to take action on the new drug application within six months (rather than the standard 10 months). The FDA reviews each application and designates each one for either priority or standard review, but a manufacturer can also request priority review. Priority review is applied to any drugs that, if approved, would greatly improve the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.

While the FDA has formal processes for both expedited and standard new drug applications, many medications and medical devices that obtain approval are later shown to have adverse effects. Medication and medical device manufacturers have a responsibility to test the safety and efficacy of their products and to properly warn patients and doctors of the associated risks.

How The FDA Approves New Medications

February 10, 2016/in Dangerous Drugs, News /by e.blizzard

With so many new medications hitting the market each year, the Food and Drug Administration (FDA) has developed an extensive application process to protect consumers by ensuring that only safe and effective medications are available for purchase or for prescribing by a physician. The FDA’s Center for Drug Evaluation and Research (CDER) is in charge of evaluating and approving new medications via a multistep application process.

Step One: Laboratory Testing

Before a medication is ever reviewed by CDER, it undergoes extensive laboratory testing that usually lasts around three to four years. The testing at this stage often involves animal trials, and if these are successful, the company manufacturing the medication submits an Investigational New Drug (IND) application. The IND application must show that the medication is reasonably safe for human trials and that its pharmacological activity justifies commercial development. If these conditions are met, CDER approves the medication for clinical trials.

Step Two: Clinical Trials

Clinical trials are broken into three phases to efficiently test several different qualities of any new medication. Phase one will establish a drug’s safety on a small number of volunteers. Phase two will measure effectiveness on several hundred patients. Phase three involves several thousand patients from different clinics and hospitals. The medication’s effectiveness is again analyzed and patients are monitored carefully for any adverse effects.

Step Three: CDER Approval

After completion of the clinical trials, the pharmaceutical manufacturer submits all of its testing data to CDER in a New Drug Application (NDA). Not only will CDER review the clinical trials, it will also analyze manufacturing specifications, stability data, dosage forms, and packaging and labeling. This process typically takes several years. If CDER determines that the benefits of the medication outweigh the risks they approve the medication

While the FDA’s approval process involves a review of new medications, the harmful effects of some pharmaceuticals are uncovered long after they have been on the market. If you suffered side effects due to your ingestion of a defective drug, you need an experienced products liability lawyer to help you get the compensation you deserve from the pharmaceutical company. Contact Blizzard Greenberg PLLC for a free case review.

The FDA Medical Device Approval Process

August 31, 2015/in Defective Devices /by e.blizzard

According to the Food and Drug Administration (FDA), more than 200,000 people are injured and as many as 2,000 are killed every year due to incidents linked to defective medical devices, such as hip and knee replacements, implants, transvaginal mesh, and contraceptive devices. In a great number of these cases, the risks are great enough that they may outweigh the potential benefits of the device, which is something patients must be aware of, if they are to be expected to make reasonable decisions regarding the use of these devices.

Over the last several years, there have been numerous reports suggesting that the FDA is placing patients at greater risk by approving many potentially invasive medical devices with roughly the same criteria that they use to approve crutches, wheelchairs, and hospital beds, which is essentially none. According to some reports, most of the moderate- to high-risk medical devices approved by the FDA in recent years did not include any sort of publicly-available scientific evidence or data that could be used to verify their efficacy and safety, even though the law requires that manufacturers of high-risk devices provide such evidence prior to approval, and that the FDA make the information publicly available.

The FDA uses three categories to classify medical devices according to risk. Class I devices include such low risk medical devices such as bandages, tongue depressors and arms legs, while Class II devices, which pose a moderate risk to patients include syringes, surgical instruments and hearing aids. Class III devices are considered high risk medical devices and are supposed to be subject to much greater scrutiny than Class I or Class II devices.

Unfortunately, too often high-risk Class III medical devices are being reviewed and approved by the FDA using a 510(k) process, which is a streamlined process that is supposedly meant to be used to approve Class I and Class II devices. However, manufacturers have apparently found a loophole of sorts. In order to qualify for a 510(k) review, the device manufacturers simply have to demonstrate that the new device is “substantially equivalent” to another device already on the market. The problem with this is, once one device is approved using this method, it becomes a “predictive” device that future 510(k) submissions can use as a reference point, which means a great many high-risk Class III devices are being approved by the FDA under the same standards as those reserved for lower-risk Class II devices, which means they’re less stringent, faster and far less expensive, all of which are good for manufacturers, but not so much for patients, since no proof of either effectiveness or safety is even necessary on the streamlined submission.

This is no small problem. According to a 2011 study published by a health research group, between 2005 and 2009, 113 medical devices were subject to recall and 80 of those made it to the market through the 510(k) process. Despite this record, according to another study in published just last year, between 2008 and 2012, of 50 new devices cleared by the FDA, only eight were actually “substantially equivalent” to devices that were cleared for market and of all previously cleared devices referenced, only about three percent had support through publicly available evidence.

Defective medical devices that are implanted inside the body can result in physical injuries that can sometimes be life-threatening and which can also cause excruciating pain and have a significant negative impact on the quality of life. The trauma often associated with these defective devices can lead to massive unforeseeable medical expenses and economic losses.

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