A newly approved drug is one that is still in the testing phase and awaiting FDA approval, or one that recently passed the FDA phase. If a drug is approved, it can be bought or leased over the counter or via a doctor. The safety and efficacy of the drug have already been established.
Since the advent of the antibiotic era, drug approval has become somewhat of a leisure sport. In the half-century since the introduction of the oral contraceptive pill, the number of new drug approvals has risen by about 50%. In the decade since Viagra was approved, the number of new drug approvals has risen by about 80%. Today, about 20 new drugs are approved for marketing each year.
The Rise In Anti-Aging Drug Approvals
The approval of anti-aging drugs has brought with it a completely new set of side effects. While the initial uses of these drugs were to treat disease, the reality is that many patients use them for non-medical reasons. Anti-aging drugs were originally developed to treat diseases like arthritis and cancer. But, since these drugs can improve patients’ quality of life, many are willing to try them for non-medical reasons.
The side effect profile of these drugs is broad. They can cause blood pressure problems and liver inflammation. One of the most serious side effects is heart failure. Because these drugs target the body’s aging process, they have the potential to increase mortality. This makes physicians nervous about prescribing them for non-medical use.
The Rising Star Of Today’s Drugs: Vipps
Even physicians who are familiar with the risks and side effects of anti-aging drugs can have difficulty keeping up with the newest generation of drugs. One of the biggest changes is the introduction of viopseq, a newly approved drug that enhances sexual libido in patients. While anti-aging drugs can be dangerous, new drugs like viopseq can also be life-changing.
In the two years since its approval by the FDA, viopseq claims to have had a positive impact on patients’ lives. According to clinical trials, those who took the drug reported increased sexual desire and function. About 70% of patients said that their sex lives were improved by the drug.
The results of the trials were so impressive that Pfizer, who markets viopseq, decided to go up against popular anti-aging drugs like Viagra and Cialis in court. In August 2019, Pfizer, along with Lilly and Boehringer Ingelheim, filed a lawsuit against the FDA claiming that the agency had unlawfully blocked the companies from discussing the benefits and risks of viopseq with physicians and patients.
While viopseq is a welcome addition to the anti-aging category, its impact on the insurance industry is likely to be minimal. Since it is not considered a ‘disease-modifying’ drug, it does not provide patients with the same level of coverage as more established anti-aging medications.
This is because it is not unusual for insurance companies to deny coverage for drugs that are still in the testing phase. In some cases, they will also deny coverage for drugs that are still undergoing FDA review. Even after a drug is approved, insurance companies generally do not cover its cost until a period of time has passed since marketing approval. In many cases, insurers will also deny coverage for drugs that are off-label, or approved for conditions that were not specified in the initial FDA approval paperwork.
What Will The Future Of Drug Approvals Look Like?
The approval of viopseq and other new drugs means that the days of the long FDA review process are over. In the past, it could take many years for a new drug to win FDA approval, if it was even approved at all. But, with new drugs coming out all the time, the agency has become increasingly reliant on new drug approvals to keep up with the competition. This has made it easier for developers to come up with new drugs, but it has also meant that physicians often have a more limited choice of treatments.
Some anti-aging physicians are already expressing worries about what the future of medicine looks like. According to an interview with the New York Times, Dr. Daniel Brooks, the director of the Institute for Aging and Human Development at Loma Linda University School of Medicine, said, “What we’re going to see is more drugs — more trials, more toxicity, more side effects. The goal is just to keep people alive longer. But at what cost?”.
The answer, probably, is that we’ll just have to wait and see. While the testing phase of new drugs might last for a decade or longer, most patients will eventually be able to find a treatment that works for them. The question is, will it be something that their doctor prescribes, or will it be a drug that they get off the internet?