FDAReview.org

Goldman Sachs analysts recently asked the question, “Is curing patients a sustainable business model?”, in a report entitled The Genome Revolution. The report outlined profit strategies for biotechnology companies engaged in gene therapy, which attempts to replace defective genes to correct genetic disorders. CNBC has since obtained the report and released the answer:

The potential to deliver ‘one shot cures’ is one of the most attractive aspects of gene therapy, genetically-engineered cell therapy and gene editing. However, such treatments offer a very different outlook with regard to recurring revenue versus chronic therapies… While this proposition carries tremendous value for patients and society, it could represent a challenge for genome medicine developers looking for sustained cash flow.

Some have taken the report to be an “outright acknowledgment from the financial services industry that curing diseases with a single treatment is not profitable.” Others allege the report demonstrates “curing patients is bad for business” more broadly.

The U.S. Food and Drug Administration recently issued a mandatory recall for Triangle Pharmanaturals, a Las Vegas-based herbal supplements company. The company’s products were linked to a shipment of kratom which tested positive for salmonella. In most cases, companies comply when the FDA recommends a product recall. Triangle Pharmanaturals, however, was not cooperative with the agency’s request, failing to return phone calls and respond to an email.

This is the first time the FDA has issued a mandatory recall for a contaminated food item. While the FDA has long had the authority to order mandatory recalls for drugs, it was granted the power to issue mandatory recalls for food products under the Food, Safety, and Modernization Act of 2011. It is also the first time the FDA has exercised this power.

Earlier this month, the U.S. Food and Drug Administration released an order indicating its intent to restrict the sale of the contraceptive device Essure, the only FDA-approved nonsurgical permanent birth control method.

Essure is extremely effective, over 99 percent successful, and popular. As of July 2017, over 750,000 devices have been sold worldwide.

This past October, the Food and Drug Administration issued a warning letter to Opternative, a company specializing in providing online eye-exams. The FDA has now made its letter public and set up a meeting with Opternative in July to make sure the company is in regulatory compliance.

The crux of the letter is that the FDA considers theses eye exams to be a Class 2 device, which requires premarket approval. Because the agency considers any device “intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body” to be approved as a Class 2 device,  it considers Opernative to be shirting around the required approval process.

In an unprecedented effort, the Food and Drug Administration is working to significantly reduce nicotine levels in cigarettes. In one policy scenario, the FDA would set a limit of 0.4 milligrams of nicotine per gram of tobacco, reducing the typical nicotine level by 97 percent.

Their goal is clear: get current smokers to quit and deter future generations from getting hooked.  Smoking is deadly, causing over 480,000 preventable deaths per year. It is also financially taxing, resulting in nearly $170 billion in direct medical cost costs annually.

A recent a WIRED article followed Arlyn Anderson, who was struggling to find care for her aging father Jim. At 91 years old with Alzheimer’s, Jim was no longer able to care for himself but still wanted to maintain his independence. When Arlyn urged him to consider relocating to a nursing home, Jim refused. Arlyn wanted to respect her father’s wishes, but between a 40 minute drive to check on him and Jim’s quickly deteriorating health, something had to change.

Situations like these are common. According to the Pew Research Center, in 2017 about 19 percent of households were composed of at least two adult generations. Further, between 2010 and 2030, the percent of the population at least 80 years old is expected to increase 79 percent while the number of family caregivers is only expected to rise one percent.

DMA, more commonly called “ecstasy” or “Molly,” is an illicit substance often taken to induce euphoria. The Controlled Substance Act considers MDMA a Schedule 1 controlled substance, which has no known medicinal benefits and a high likelihood of abuse.

Penalties for using or distributing MDMA are considerably high even for a Schedule 1 substance. In 2001, the U.S. federal government increased penalties for people convicted of dispensing over 50 grams of MDMA to a four-year prison sentence and up to $4 million in fines. These penalties could double if the buyer was harmed from the exchange. Similarly, possessing 5 grams of MDMA can result in a prison sentence ranging from 4 to 50 years.