FDA drug approval rate reaches new high

The FDA Is Basically Approving Everything. Here’s The Data To Prove It

fda-approval-rates
Remember when the FDA rejected drugs? The FDA points out that one reason that drug approval rates are going up is because it is doing its job, as defined by Congress

We just got treated to a whole lot of drama last week as to whether Addyi, a drug to boost women’s libidos, would be approved. But based on data analysis commissioned by Forbes from BioMedTracker, that approval was probably a foregone conclusion.”…

… “But the risks of speeding up approvals should be pretty clear, too. In the late 1990s and early 2000s, there was a boom of new drug approvals. In 1999, the FDA approved two drugs that became synonymous with drug safety scandals: Vioxx, which was withdrawn from the market by Merck, and Avandia, made by GlaxoSmithKline, which later had its use severely restricted. The approval boom is good only so long as it doesn’t trigger another drug safety conference.”

Read The FDA Is Basically Approving Everything. Here’s The Data To Prove It, Forbes, AUG 20, 2015.

Addyi Flibanserin HSDD Drug is FDA-approved!

HSDD treatment by Sprout Pharmaceuticals

Sprout-pharma--Women image
Meet addyithe first of her kind – and The Sprout Pharmaceuticals women.

This post content is published by the U.S. Food and Drug AdministrationProtecting and Promoting Your Health.

FDA approves first treatment for sexual desire disorder

The U.S. Food and Drug Administration today approved Addyi (flibanserin) to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. Prior to Addyi’s approval, there were no FDA-approved treatments for sexual desire disorders in men or women.

“Today’s approval provides women distressed by their low sexual desire with an approved treatment option,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER). “The FDA strives to protect and advance the health of women, and we are committed to supporting the development of safe and effective treatments for female sexual dysfunction.”

HSDD is characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to a co-existing medical or psychiatric condition, problems within the relationship, or the effects of a medication or other drug substance. HSDD is acquired when it develops in a patient who previously had no problems with sexual desire. HSDD is generalized when it occurs regardless of the type of sexual activity, the situation or the sexual partner.

“Because of a potentially serious interaction with alcohol, treatment with Addyi will only be available through certified health care professionals and certified pharmacies,” continued Dr. Woodcock. “Patients and prescribers should fully understand the risks associated with the use of Addyi before considering treatment.”

Addyi can cause severely low blood pressure (hypotension) and loss of consciousness (syncope). These risks are increased and more severe when patients drink alcohol or take Addyi with certain medicines (known as moderate or strong CYP3A4 inhibitors) that interfere with the breakdown of Addyi in the body. Because of the alcohol interaction, the use of alcohol is contraindicated while taking Addyi. Health care professionals must assess the likelihood of the patient reliably abstaining from alcohol before prescribing Addyi.

Addyi is being approved with a risk evaluation and mitigation strategy (REMS), which includes elements to assure safe use (ETASU). The FDA is requiring this REMS because of the increased risk of severe hypotension and syncope due to the interaction between Addyi and alcohol. The REMS requires that prescribers be certified with the REMS program by enrolling and completing training. Certified prescribers must counsel patients using a Patient-Provider Agreement Form about the increased risk of severe hypotension and syncope and about the importance of not drinking alcohol during treatment with Addyi. Additionally, pharmacies must be certified with the REMS program by enrolling and completing training. Certified pharmacies must only dispense Addyi to patients with a prescription from a certified prescriber. Additionally, pharmacists must counsel patients prior to dispensing not to drink alcohol during treatment with Addyi.

Addyi is also being approved with a Boxed Warning to highlight the risks of severe hypotension and syncope in patients who drink alcohol during treatment with Addyi, in those who also use moderate or strong CYP3A4 inhibitors, and in those who have liver impairment. Addyi is contraindicated in these patients. In addition, the FDA is requiring the company that owns Addyi to conduct three well-designed studies in women to better understand the known serious risks of the interaction between Addyi and alcohol.

Addyi is a serotonin 1A receptor agonist and a serotonin 2A receptor antagonist, but the mechanism by which the drug improves sexual desire and related distress is not known. Addyi is taken once daily. It is dosed at bedtime to help decrease the risk of adverse events occurring due to possible hypotension, syncope and central nervous system depression (such as sleepiness and sedation). Patients should discontinue treatment after eight weeks if they do not report an improvement in sexual desire and associated distress.

The effectiveness of the 100 mg bedtime dose of Addyi was evaluated in three 24-week randomized, double-blind, placebo-controlled trials in about 2,400 premenopausal women with acquired, generalized HSDD. The average age of the trial participants was 36 years, with an average duration of HSDD of approximately five years. In these trials, women counted the number of satisfying sexual events, reported sexual desire over the preceding four weeks (scored on a range of 1.2 to 6.0) and reported distress related to low sexual desire (on a range of 0 to 4). On average, treatment with Addyi increased the number of satisfying sexual events by 0.5 to one additional event per month over placebo increased the sexual desire score by 0.3 to 0.4 over placebo, and decreased the distress score related to sexual desire by 0.3 to 0.4 over placebo. Additional analyses explored whether the improvements with Addyi were meaningful to patients, taking into account the effects of treatment seen among those patients who reported feeling much improved or very much improved overall. Across the three trials, about 10 percent more Addyi-treated patients than placebo-treated patients reported meaningful improvements in satisfying sexual events, sexual desire or distress. Addyi has not been shown to enhance sexual performance.

The 100 mg bedtime dose of Addyi has been administered to about 3,000 generally healthy premenopausal women with acquired, generalized HSDD in clinical trials, of whom about 1,700 received treatment for at least six months and 850 received treatment for at least one year.

The most common adverse reactions associated with the use of Addyi are dizziness, somnolence (sleepiness), nausea, fatigue, insomnia and dry mouth.

The FDA has recognized for some time the challenges involved in developing treatments for female sexual dysfunction. The FDA held a public Patient-Focused Drug Development meeting and scientific workshop on female sexual dysfunction on October 27 and October 28, 2014, to solicit perspectives directly from patients about their condition and its impact on daily life, and to discuss the scientific challenges related to developing drugs to treat these disorders. The FDA continues to encourage drug development in this area.

Consumers and health care professionals are encouraged to report adverse reactions from the use of Addyi to the FDA’s MedWatch Adverse Event Reporting program at www.fda.gov/MedWatch or by calling 1-800-FDA-1088.

Addyi is marketed by Sprout Pharmaceuticals, based in Raleigh, North Carolina.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. ”

More information

  • Full Prescribing Information, addyi, Revised: 8/2015.
  • Medication Guide, addyi, 8/2015.
  • As FDA approves ‘pink Viagra’ for women, controversy persists,
    latimes, AUG 19, 2015.
  • FDA approves ‘female Viagra’ pill Flibanserin after two rejections,
    theguardian, AUG 18, 2015.
  • FDA Approves Addyi (Flibanserin), ‘A Milestone Moment’ In Women’s Health,
    Forbes, AUG 18, 2015.

A Guide to Prescription Drugs in the United States

Many people in the US regularly use prescription drugs

Guide to Prescription Drugs in the U.S.
Many people in the United States regularly use prescription drugs.

Becoming more familiar with prescription drug development can help many Americans make decisions that are more informed in regards to their medications:

  • Discovery and Subsequent Development
  • Preclinical Research
  • Clinical Research
  • FDA Review
  • Post Market Safety Monitoring
  • Online Tools and Further Research
Sources and more information

Flibanserin explained on Video

What Big Pharma Doesn’t Want You To Know About “Female Viagra”

An investigation by ThinkProgress reveals that the Flibanserin drug‘s public relations campaign is highly misleading and its effectiveness is modest at best… video published on 14 August 2015.

More information
  • What Big Pharma Doesn’t Want You To Know About ‘Female Viagra’, thinkprogress, 14 August 2015.
  • Watch more pharma videos on @DES_Journal YT channel.

Dr Frances Oldham Kelsey: 20th-century American heroine for her role in the Thalidomide case

Frances Oldham Kelsey, F.D.A. stickler who saved U.S. babies from Thalidomide, dies at 101

Dr-Frances-Oldham-Kelsey
Dr Frances Oldham Kelsey, the Canadian doctor who played a central role in preventing the drug thalidomide being distributed in the US, has died at 101. Image of Kelsey with President John F. Kennedy signing the 1962 Drug Amendments (FDA051) by the The U.S. Food and Drug Administration.

A Londoner who’s kept the scourge of thalidomide out of the United States has died, leaving behind a legacy of achievement that made her a heroine south of the border.

In 1962, President John F. Kennedy awarded Kelsey the highest honour given to a civilian in the U.S., the President’s Award for Distinguished Federal Civilian Service. Kelsey was only the second woman to receive the award. The new laws would pass and Kelsey would play a leading role giving them force.

Dr Frances Kelsey spent her final years here with family after a trail-blazing career that once led the Baltimore Post-Examiner to call her America’s greatest living heroine.

Sources and more information
  • Frances Oldham Kelsey, F.D.A. Stickler Who Saved U.S. Babies From Thalidomide,
    Dies at 101
    , NYtimes, AUG. 7, 2015.
  • Frances Oldham Kelsey – a true American hero turns 100,
    Baltimore Post-Examiner, July 26, 2014.
  • America’s Greatest Living Heroine Frances Oldham Kelsey – 98 and forgotten,
    Baltimore Post-Examiner, February 11, 2013.
  • Thalidomide and the 1962 Kefauver-Harris Drug Amendments, FDA.
  • About the life and work of Dr. Kelsey: Autobiographical Reflections, FDA.

When Drug Manufacturers delay Disclosure of Serious and Unexpected Adverse Events to the FDA

Some adverse drug events not reported by manufacturers to FDA by 15-day mark

image of drugs
About 10 percent of serious and unexpected adverse events are not reported by drug manufacturers to the U.S. Food and Drug Administration under the 15-day timeframe set out in federal regulations, according to an article published online by JAMA Internal Medicine. Drugs image by Rennett Stowe.

2015 Study Abstract

This study investigates patient and event characteristics associated with manufacturers’ delayed submission of expedited adverse event reports to the US Food and Drug Administration.

Federal regulations define adverse drug events as those “associated with the use of a drug in humans whether or not considered drug related”. Health care professionals and consumers can voluntarily report adverse drug events directly to the US Food and Drug Administration (FDA) or the drug manufacturer. Serious adverse events (AEs) are defined by the regulation as those involving “death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect.” Unexpected AEs are defined as those involving “any adverse drug experience that is not listed in the current labeling for the drug product.” Serious and unexpected events are classified as expedited, and manufacturers receiving any such reports are mandated to forward them to the FDA “as soon as possible but in no case later than 15 calendar days of the initial receipt of the information.” The regulation also requests that the manufacturer conduct an investigation and forward findings as follow-up reports to the FDA. Previous studies highlighted that reports by manufacturers to the FDA of serious adverse drug events have increased steadily during the past decade. Manufacturer compliance with the regulation to report serious and unexpected AEs to the FDA within 15 calendar days is unknown, although some media coverage has offered anecdotal examples of delays. As the FDA uses this information to update drug warnings, delays in reporting can have important public health consequences, particularly if manufacturers selectively delay reporting based on relevant patient outcomes. We investigated patient and event characteristics associated with manufacturers’ delayed submission of the expedited reports to the FDA.

Sources and more information
  • Some adverse drug events not reported by manufacturers to FDA by 15-day mark, MedicalXpress, July 27, 2015.
  • Drug Manufacturers’ Delayed Disclosure of Serious and Unexpected Adverse Events to the US Food and Drug Administration, JAMA Internal Medicine,  doi:10.1001/jamainternmed.2015.3565, July 27, 2015.

“Female Viagra” gets approval from FDA, with conditions

Flibanserin drug is backed by an FDA panel… theDESK video

Today on theDESK, the FDA is on the verge of approving a drug for women that acts much like Viagra, but there are serious side effects and questions about Flibanserin effectiveness.. Video published on 5 Jun 2015 by UPROXX.

More information

Will the “Female Viagra” really help women?

Concerns remain for the flibanserin drug, twice rejected by the FDA

pink-viagra image
The makers of the flibanserin pill intended to boost sexual desire in women will try again this week to persuade regulators that the drug warrants approval after two rejections. Image via Net Doktor.

Later today, a committee of advisors to the Food and Drug Administration will vote on whether or not the agency should approve flibanserin – the much-hyped yet controversial “female Viagra.” However, the drug has already been rejected twice previously by the organization, who cite safety concerns. In the wake of those decisions, battle lines have been drawn between:

  • those who feel the agency is discriminating against the sexual health of women
  • and those who feel the language of sexual equality has been hijacked in an attempt to force an ineffective and unsafe drug on the market.

MedicalNewsToday took a look at both sides of this dramatic debate

More information
  • Will ‘the female Viagra’ really help women?, MedicalNewsToday, 4 June 2015.
  • Pink Viagra may be coming soon (but for teetotalers, only!), healthnewsreview,
  • Concerns remain for “Viagra for women” twice rejected by FDA, denverpost, 06/03/2015.
  • Will Female Viagra Be An FDA Boner?, Science 2.0, May 28th 2015.
  • ‘Viagra for Women’ Gets Push for F.D.A. Approval, The New York Times, MAY 31, 2015.

Registry Information for Pregnant Women

Share your experience with medicines

Share your experience with medicines. Sign up for a pregnancy exposure registry. You can help other pregnant women and doctors find out more about the safety of medicines used during pregnancy.

Many women need to take medicine while they are pregnant. Some women take medicines for health problems, like diabetes or high blood pressure, that can start or get worse when a woman is pregnant. Some women use medicine before they find out they are pregnant.

A pregnancy exposure registry is a study that collects health information from women who take prescription medicines or vaccines when they are pregnant. Information is also collected on the newborn baby. This information is compared with women who have not taken medicine during pregnancy.

Enrolling in a pregnancy exposure registry can help improve safety information for medicines used during pregnancy and can be used to update drug labeling. Learn more about how you can help.

Image via U.S. Food and Drug Administration.

Do our bodies safely break down BPA? Fat chance

In Vitro Effects of Bisphenol A β-D-Glucuronide (BPA-G) on Adipogenesis in Human and Murine Preadipocytes

This post content is written by Brian Bienkowski, published by Environmental Health News – covering the most important stories on environmental and health issues every day.

obesity image
Industry has long contended bisphenol-A breaks down harmlessly in our bodies. New research suggests that we transform it into a compound linked to obesity. Image by Tony Alter.

A new study suggests the long-held industry assumption that bisphenol-A breaks down safely in the human body is incorrect. Instead, researchers say, the body transforms the ubiquitous chemical additive into a compound that might spur obesity.

The study is the first to find that people’s bodies metabolize Bisphenol A (BPA) — a chemical found in most people and used in polycarbonate plastic, food cans and paper receipts — into something that impacts our cells and may make us fat.

The research, from Health Canada, challenges an untested assumption that our liver metabolizes BPA into a form that doesn’t impact our health.

This shows we can’t just say things like ‘because it’s a metabolite, it means it’s not active’,” said Laura Vandenberg, an assistant professor of environmental health at the University of Massachusetts Amherst who was not involved in the study. “You have to do a study.”

People are exposed to BPA throughout the day, mostly through diet, as it can leach from canned goods and plastic storage containers into food, but also through dust and water.

Within about 6 hours of exposure, our liver metabolizes about half the concentration. Most of that — about 80 to 90 percent — is converted into a metabolite called BPA-Glucuronide, which is eventually excreted.

The Health Canada researchers treated both mouse and human cells with BPA-Glucuronide. The treated cells had a “significant increase in lipid accumulation,” according to the study results. BPA-Glucuronide is “not an inactive metabolite as previously believed but is in fact biologically active,” the Health Canada authors wrote in the study published this week in Environmental Health Perspectives.

Not all cells will accumulate lipids, said Thomas Zoeller, a University of Massachusetts Amherst professor who was not involved in the study. Testing whether or not cells accumulate lipids is “a very simple way of demonstrating that cells are becoming fat cells,” he said.

Hopefully this [study] stops us from making assumptions about endocrine disrupting chemicals in general,” he said.

The liver is our body’s filter, but it doesn’t always neutralize harmful compounds. “Metabolism’s purpose isn’t necessarily a cleaning process. The liver just takes nasty things and turns them into a form we can get out of our body,” Vandenberg said.

BPA already has been linked to obesity in both human and animal studies. The associations are especially prevalent for children exposed while they’re developing.

Researchers believe BPA does so by mimicking estrogen hormones, but its metabolite doesn’t appear to do so. In figuring out why metabolized BPA appears to spur fat cells, Zoeller said, it’s possible that BPA-Glucuronide is “hitting certain receptors in cells”.

Health Canada researchers were only looking at this one possible health outcome. “There could be other [health] impacts,” Zoeller said.

In recent studies BPA-Glucuronide has been found in human blood and urine at higher concentration than just plain BPA.

Industry representatives, however, argue the doses used were much higher than what would be found in people.

Steve Hentges, a spokesperson for the American Chemistry Council, which represents chemical manufacturers, said the concentrations used in which the researchers saw increased fat cells were thousands of times higher than the concentrations of BPA-Glucuronide that could be present in human blood from consumer exposure to BPA.

There were no statistically significant observations at lower BPA-G concentrations, all of which are higher than human blood concentrations,” he said in the emailed response.

Zoeller agreed the dose was high but said “the concentration is much less important than the fact that here is a group testing an assumption that’s uniformly been made.” Vandenberg said the range is not that far off from what has been found in some people’s blood.

The U.S. Food and Drug Administration is reviewing the Health Canada study but couldn’t comment before Environmental Health News’ deadline, said spokesperson Marianna Naum in an email.

The agency continues to study BPA and states on its website that federal research models “showed that BPA is rapidly metabolized and eliminated through feces and urine.

Health Canada, which was not able to provide interviews for this article, has maintained a similar stance to the U.S. FDA, stating on its website that it “has concluded that the current dietary exposure to BPA through food packaging uses is not expected to pose a health risk to the general population, including newborns and infants.”

However, the fact that Health Canada even conducted such a study is a big deal, Vandenberg said.

Health Canada is a regulatory body and this is pretty forward thinking science,” she said. “Hopefully this is a bell that can ring for scientists working for other regulatory agencies.”

For questions or feedback about this piece, contact Brian Bienkowski.