Medications
Resources
Basic InformationLatest News
COVID Drug Remdesivir Could Cost Up to $3,120 Per Patient, Maker SaysHigh Costs Lead Millions of Americans to Shop Abroad for Rx DrugsFDA Pulls Emergency Approval of Hydroxychloroquine for COVID-19How Ritalin Works in the BrainFDA Pulls Heartburn Drug Zantac From MarketTaking More Antibiotics May Up Odds for HospitalizationAllergy Med Singulair to Get 'Black Box' Warning Over Psych Side Effects: FDAU.S. Drug Prices Have Risen Three Times Faster Than InflationUse Pot? It Can Interact With Your Meds in Harmful WaysToo Many Antibiotics, Opioids Given to Dental Patients in the ERBrand-Name Rx Rise After Docs Get Drug Company Perks: StudyAs Prices Rise for Parkinson's, Alzheimer's Meds, Patients Go WithoutPrice Hikes Have Patients Turning to Craigslist for Insulin, Asthma InhalersAI May Help Guide Patients to Most Effective Antidepressant1 in 4 Gets Unneeded Antibiotics at Children's HospitalsStudy Finds 'No Clear Rationale' for 45% of Antibiotic PrescriptionsAre Antibiotics a Recipe for Obesity in Childhood?Do You Take Warfarin? Time of Day Might Not MatterNew Drugs Getting FDA's Blessing Faster, but Is That a Good Thing?Health Tip: Acetaminophen SafetyTwo More Heartburn Meds Recalled Due to Possible CarcinogenMany Drugstores Misinform on Disposal of Unused MedsHealth Tip: How to Remember to Take Your MedicationsFDA to Allow States to Import Prescription Drugs From Other CountriesOver 40% of Antibiotics Could Be 'Inappropriately' PrescribedFDA Testing Levels of Carcinogen in Diabetes Drug MetforminTaking Several Prescription Drugs May Trigger Serious Side EffectsPenicillin Allergy Less Common Than Thought: StudyMany Older Americans Misuse Antibiotics: PollAntibiotics Not Recommended for Most Toothaches, New Guideline SaysHealth Tip: Taking Anti-Inflammatory DrugsMany Common Meds Could Alter Your MicrobiomeWhen Meds Are Free, Patients Take Them More OftenMaker Halts Distribution of Generic Zantac Due to Possible CarcinogenKids Often Prescribed Drugs 'Off-Label,' Raising ConcernsHeartburn Drug Zantac May Contain Small Amounts of Known Carcinogen, FDA SaysHealth Tip: Take Over-the-Counter Medication WiselyA Prescription for Medicating Your Child SafelyHealth Tip: Taking Dietary SupplementsTrump Administration Announces Plan to Allow Cheaper Drug Imports From CanadaAre Too Many Kids Prescribed Antihistamines?Some Meds and Driving a Dangerous DuoHealth Tip: Giving Medicine Safely to ChildrenHigher Cost of New Cholesterol Drugs Putting Patients at Risk: StudyMany Americans Take Antibiotics Without a PrescriptionHealth Tip: Packing Prescriptions for Travel
Questions and AnswersVideosLinksBook Reviews
Related Topics

Anxiety Disorders
Depression: Depression & Related Conditions
Medical Disorders
Mental Disorders
Mental Health Professions

New Drugs Getting FDA's Blessing Faster, but Is That a Good Thing?

HealthDay News
by By Dennis Thompson
HealthDay Reporter
Updated: Jan 14th 2020

new article illustration

TUESDAY, Jan. 14, 2020 (HealthDay News) -- New drugs are being approved by the U.S. Food and Drug Administration for patients based on less and less solid evidence, thanks to incentive programs that have been created to promote drug development, a new study shows.

Researchers report that more than 8 out of 10 new drugs in 2018 benefitted from at least one special program that streamlines the approval process.

The result is that patients are being prescribed pricey new medications that have not been tested as rigorously, said lead researcher Jonathan Darrow, an assistant professor at Harvard Medical School.

"The evidence standards have changed, but it's not clear that physicians, let alone patients, understand either the basic FDA approval standard or that requirements have become increasingly flexible over the past 40 years," Darrow said.

The share of new drugs supported by two strong clinical trials, rather than just one, decreased from 81% to 53% between the 1990s and the 2010s, researchers found.

The time that the FDA spent reviewing each new drug dropped during the same period, from 2.8 years in the late 1980s to about 7.6 months in 2018, Darrow added.

This might be good news if highly effective new drugs were reaching the market quicker, but other research has found that the large majority of newly approved drugs offer modest benefits over existing therapies, he said.

"In many cases, you can get almost all of the benefit of the new drugs by taking older drugs," such as generics, Darrow said.

The programs also haven't really improved the number of new drugs approved each year, either.

"Even with that flexibility, there has been no strong upward trend in the number of drug approvals, which on average has remained about 30 new drugs approved per year since the 1980s," Darrow said.

The average annual number of new drug approvals was 34 from 1990-1999, decreasing to 25 from 2000-2009 and then increasing to 41 from 2010-2018, researchers found.

In a statement, the FDA said that the new study "covers a very wide range of issues," and "we are concerned that the researchers do not adequately consider the marked changes in the types of drugs and the patient populations targeted by development programs that FDA now reviews, compared to those from just 10 or 20 years ago, nor the type, quality, and extent of data FDA routinely receives now compared to decades ago."

The agency added that it believes that a failure to take those "marked changes" into account "can result in inaccurate conclusions."

HealthDay also reached out to PhRMA, a trade group representing the pharmaceutical industry, but did not receive comment.

Since the 1980s, various programs have been enacted by U.S. Congress or developed by the FDA to promote the creation of drugs for rare diseases or accelerate approval of promising medications that could benefit multitudes, researchers said in background notes.

"In 2018, more than 80% of new drugs benefitted from at least one special program," Darrow said.

These programs have weakened the review process by requiring the FDA to accept more flexible evidence, he said.

For example, evidence of a drug's effect on cholesterol levels or tumor size can be used to get it approved, rather than evidence that the drug helped people live longer or feel better or avoid emergencies such a heart attacks, Darrow said.

But there's been no benefit from these programs in terms of how long it takes a company to create a new drug, he said.

"We found there was a relatively stable period between when clinical trials began and when drugs were approved. We did not see a steep decline in the clinical development period," Darrow said.

Disturbingly, the FDA has also become more financially reliant on money from pharmaceutical companies, researchers found.

The amount of the FDA budget that comes from the pharmaceutical industry has increased from about $300 million in the 1990s to just over $4 billion in the 2010s, researchers found. These fees are used to accelerate review times, researchers said.

The FDA has tried to offset the accelerated approval process by requiring companies to track drug effectiveness and safety after it's reached the market, Darrow noted.

"But in the meantime, the agency is allowing doctors and patients to use the drug while the additional information is being collected," Darrow said. "Once drugs are available, they are available to all patients due to off-label prescribing, and those patients may not realize those drugs were approved on the basis of limited evidence or that more evidence is still being collected."

The findings were published Jan. 14 in the Journal of the American Medical Association.

These accelerated review programs have driven up health care costs needlessly, said Dr. Joshua Sharfstein, vice dean for public health practice and community engagement at Johns Hopkins Bloomberg School of Public Health in Baltimore.

The new study provides "an opportunity to pause for a minute and say, 'Can we get the benefit that's intended at perhaps a lower cost, and focus the incentive on products that are going to make the most difference?'" said Sharfstein, who wasn't part of the research.

For example, the Orphan Drug Act was intended to promote the development of drugs for very rare diseases, but "a lot of these incentives have benefitted companies that are selling drugs for many, many patients," Sharfstein said.

"I think that it's very important for FDA to study which incentives, under what circumstances, really lead to medications that make a huge difference for patients, and propose more efficient ways to apply those incentives," Sharfstein noted.

More information

The U.S. Food and Drug Administration has more about the drug development and review process.




Facebook

Amazon Smile

 

Children and Adult services are available now with no wait time.  

Please contact HBH at 860-548-0101, option 2.

 


powered by centersite dot net