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FDA Fast-Track Programs for Drugs and Medical Devices

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Pharmaceutical and medical device companies often get their products approved quickly by the FDA through fast-track and the 510(k) premarket processes. This means some drugs and devices are not tested fully before being sold, increasing the risk they can injure or hurt people.

The U.S. Food and Drug Administration’s (FDA) expedited approval programs – also referred to as fast-track programs ­­– give doctors and patients quicker access to new drugs and devices that are sorely needed to treat a number of health issues. The FDA created these programs for new drugs in 1992 under the Prescription Drug User Fee Act (PDUFA) with the aim of meeting treatment needs for serious or life-threatening medical conditions more quickly.

PDUFA changed the way drugs can be approved and sped up the process by giving the FDA more money to increase staff. Prior to the law, FDA funding came only from the U.S. government, which did not provide enough resources to push new drugs through the approval process fast enough to meet patient demands. In fact, the process often took so long that drug companies complained that FDA delays cost them money. For the first time, the agency began taking fees from the very companies whose drugs they were tasked to review. While this provided the struggling agency with funding to get more work done, some experts worried about a conflict of interest.

Another type of expedited program created in 1976, the 510(k) Premarket Notification program, allows medical device companies to gain clearance for a new product if its design and functionality are based on a device that already received FDA approval. Clearance can come despite the lack of full testing on the new device. While not considered a fast-track option, the 510(k) shortens the time it takes for devices to hit the market. Device companies pay an application fee when they want to have their new near-identical products evaluated by the FDA.

Fast-track programs and the 510(k) program draw criticism because they put speed before safety. Some experts think that in its rush to approve or clear drugs and devices, the FDA allows more dangerous products to reach the market.

The FDA states that it “has been vigilant in assuring that reducing the time necessary for drug development has not compromised the safety and effectiveness of drugs for patients with serious conditions.”

Still, new data points to the fact that there were fewer black box warnings and fewer drugs pulled off the market because of safety concerns prior to the PDUFA. Before the FDA even gathers enough data to require companies to release safety warnings for side effects, patients must take their chances with drugs and devices that may cause serious injury.

Drugs that include Xarelto (blood thinner), Avandia (diabetes), Risperdal (antipsychotic), Actos (diabetes) and Lipitor (statin), all approved after the PDUFA, caused a number of side effects that patients were not warned about – some fatal. Manufacturers pushed medical devices like metal-on-metal hip implants, power morcellators and transvaginal mesh through the 510(k) program, and these devices caused devastating injuries to thousands of people. Studies now link power morcellators to deadly pelvic cancers.

Drug and device companies now face mounting lawsuits that claim they failed to warn the public and produced faulty products.

Expedited Drug Approval Programs

The FDA has four expedited programs for drug approval:

  • Fast-track designation
  • Breakthrough therapy designation
  • Accelerated approval
  • Priority review designation

Each has its own set of criteria, but one drug may qualify for one or more of the programs. This means there are multiple ways for drug companies to gain faster approval.

Fast Track Designation

Fast Track Designation hastens the review of drugs for serious conditions and unmet medical needs. The FDA does not have a concrete way to determine what it considers “serious,” but in general it considers whether a new drug will improve survival, day-to-day functioning and prevent the medical condition from getting worse.

Some of the diseases the agency considers serious include obvious ones like AIDS, Alzheimer’s and cancer. Others in include epilepsy, depression and diabetes.

A drug automatically fulfills an unmet need if there are no available treatments. If treatments are available, new drugs may still be considered if they are less toxic than those already on the market, have a treatment advantage or may help people for whom current drugs don’t work.

Drug companies can file for fast-track approval at any time during a drug’s development. Once the FDA approves an application into the program, it remains in close contact with the drug company during the approval process. Companies can also submit all relevant paperwork at one time, which differs from the traditional step-by-step drug approval process. Drugs that receive fast-track designation are also eligible for Accelerated Approval and Priority Review.

Breakthrough Therapy

Breakthrough Therapy designation expedites the approval of drugs that treat serious conditions. In order to qualify, a drug must have preliminary evidence that shows it is superior to a drug already on the market on “clinically significant endpoints.” In other words, the drug has to make a difference on survival time or on serious symptoms of a disease.

The FDA works closely with companies who produce drugs eligible for this designation and even helps guide them through development of the drug. Senior FDA managers are also involved in these projects.

Medications that qualify also receive the benefits of Fast-Track and Priority Review.

Accelerated Approval

Accelerated Approval regulations allow the FDA to approve drugs intended to treat serious conditions using clinical evidence that shows a possible benefit called a surrogate endpoint. Endpoints are the desired effects of a drug, such as extending life or reducing symptoms. Surrogate endpoints do not have to be as adequate or well controlled as actual clinical endpoints, and they are only “Priority Review

When drugs gain Priority Review status, the FDA diverts many of its resources to the review of a drug, helping it get approved faster. Companies must provide evidence that the new medication:

  • Is highly effective in treating, preventing or diagnosing a disease or condition.
  • Eliminates or substantially eliminates adverse reactions that prevent treatment.
  • Is safe and effective in a new subpopulation of people (such as elderly patients or children).
  • Can help patients be more compliant with taking it.

These four fast track options apply to drugs only, but medical devices have their own speedy process called the 510(k) premarket notification program.

510(k) Premarket Program

The 510(k) program allows some medical devices that the FDA determines to be low risk on the market without comprehensive testing through a process called premarket notification. If a device is already on the market that is “substantially equivalent” to the new product, it is allowed on the market. Critics say while patients and doctors get access to new products quicker, there may be a greater chance that those who receive the devices may also be at greater risk of suffering complications from poorly tested devices.

For example, transvaginal or pelvic mesh implants used to treat pelvic organ prolapse or stress urinary incontinence caused a number of women permanent and life changing injuries. The mesh is classified as Class II, which means it is exempt from rigorous testing. Many mesh companies received clearance by basing their products on mesh devices already on the market – in this case, a device pulled off the market for safety concerns called the ProtoGen.

The 510(k) is a part of the Medical Device Amendments to the Federal Food, Drug and Cosmetic Act enacted in 1976. Under the Act, all medical devices are classified into three categories depending on the risk that serious injury or death may occur.

The FDA defines the classes as:

  • Class I: These devices are not considered high risk and include items such as tongue depressors, bandages and arm slings. The FDA does not extensively review these products with 95 percent receiving exemption from regulatory process. Of all devices on the market, 47 percent fall in this category.
  • Class II: The risk from these devices is considered moderate but not risky enough to merit companies providing extensive safety and effectiveness data to the FDA. About 43 percent of all devices belong in this category.
  • Class III: This is the highest risk category, and devices such as pacemakers and breast implants are a part of this class. These products must all go through the full premarket approval processes, which means proof of safety and effectiveness must be given to the FDA. Only 10 percent of all devices fall in this category.

Hip and knee implants are pre-amendment Class III devices. They are exempt from rigorous testing as long as they are “substantially equivalent” to devices already on the market.

After the FDA became aware of the substantial injuries caused by metal-on-metal hips and transvaginal mesh, it proposed reclassifying the devices to Class III – requiring manufacturers to turn in studies proving safety. Regulators have yet to make a final ruling.

Instead of doing additional safety testing that can be time consuming and expensive, some device companies simply remove risky products from the market.

Fast-Track May Let More Dangerous Drugs on the Market

Although consumer advocates worried drug industry money may compromise the FDA, Congress renewed the act several times since 1992. The U.S. House of Reps. passed the 21st Century Cures Act in July 2015 which would only hurry the approval process even more if approved by the president.

Meanwhile, a 2014 study published in Health Affairs found that after the PDUFA, more drugs were either pulled off the market or received black box warnings. According to researchers, for every 100 drugs, companies either pulled from the market or added warnings to 34 of them.

“In its hurry, the FDA is apparently failing to distinguish useful drugs from toxic ones, and more dangerous drugs are slipping through,” study author Cassie Frank of Harvard Medical School told The Wall Street Journal. “By the time many drugs receive serious safety warnings, millions of Americans have already been exposed to their side effects, which can sometimes be fatal.”

A 2014 investigation by MedPageToday and the Milwaukee Journal Sentinel found the FDA approved 40 cancer treatments without proof that they extended life during the last 10 years. The investigators discovered that of 26 drugs approved using surrogate endpoints from 2004 to 2011, only three found proof of extended survival benefits during postmarket research. No proof was found for 22 of the drugs, but they remain on the market.

“What we’ve been doing is pushing more and more drugs into the market to make more and more of a market,” Dr. Leonard Saltz of the Memorial Sloan Kettering Cancer Center told MedPage Today. “And we’re doing so with the fantasy that we’re doing better. But the evidence doesn’t always support that.”

A 2015 study published in the Journal of the American Medical Association Internal Medicine found 31 drugs approved from 2008-2012 using surrogate endpoints failed to show survival benefits after four years of opportunities for follow-up studies.

Experts believe a reform of the accelerated approval system is necessary.