EpiPen Pricing Controversy Reveals Ignorance about Market Competition

A recent episode of CNN’s Boss Files podcast featured Heather Bresch, CEO of Mylan and the first woman to run a Fortune 500 pharmaceutical company. The podcast focused primarily on her journey to success. However, roughly 40 minutes in, Bresch was questioned about her pricing strategy for EpiPen, the epinephrine auto-injector for treating emergency allergic reactions.

Mylan acquired the right to sell EpiPen in 2007 and, under Bresch’s leadership, EpiPen prices were raised nearly 400 percent in late 2015. In mid-2016, Mylan released a generic EpiPen, which sold for about $300 for a 2-pack (50 percent less expensive than the name-brand version). When questioned about Mylan’s pricing and promotion strategy, Bresch explained that patients “needed a solution and wanted a solution” and that her generic device provided both.

FDA Moves Closer to Approving Ecstasy

Last August, the U.S. Food and Drug Administration began testing MDMA (ecstasy) for treating post-traumatic stress disorder. The FDA also granted MDMA breakthrough therapy status to expedite the approval process by making it easier for drugmakers to begin clinical trials.

Recently, MDMA passed phase 2 of the FDA’s four-phase drug-approval process. Although phase 3 requires a large sample and a longer period to complete, the drugs that reach this phase are typically approved. Evidence of MDMA’s “impressive” therapeutic benefits is now published in The Lancet Psychiatry journal. Stemming from the drug’s successful clinical trial results, many expect MDMA to be approved for therapeutic use by 2021.

Right-to-Try Law Signed!

On May 30, President Trump signed a bill into law allowing terminally ill patients access to potentially lifesaving drugs before they are approved by the Food and Drug Administration. This bill, referred to as right-to-try legislation, provides an unprecedented curtailing of the FDA’s regulatory authority.

At a bill signing ceremony, the president remarked, “Thousands of terminally ill Americans will finally have hope.” He is right. With nearly 25,000 patients dying annually while waiting for the FDA to approve potentially lifesaving drugs, opening additional avenues for these patients is paramount. Although right-to-try is inherently risky, easier access to experimental drugs provides more options in literally hopeless situations.

Curing Diseases Is Sustainable, Government in Healthcare Is Not

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.

FDA Issues First Mandatory Recall for Contaminated Food

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.

FDA Restricts Sale of Contraceptive Device

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.

FDA Cracks Down on Online Eye-Exam Company

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.

The FDA Plans to Regulate Nicotine in Cigarettes

47043924 - open pack of cigarettes with the filter

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.

Medical Apps: Improving Healthcare on a Global Scale

A recent survey of physician wait times in the United States found the average wait time for a new patient to see a physician in 15 metropolitan areas has increased 30 percent since 2014. This statistic includes an average wait time of over two months to get a physical in Boston, a month to get a heart evaluation in Washington, and one month for a skin exam anywhere in the nation. With a current U.S. shortage of 61,000 to 94,700 physicians, longer wait times are likely to continue.

Fortunately for patients tired of waiting for swift medical attention, health apps are providing solutions.

Health apps use smartphone technology to provide medical assistance or access to medical professionals. More than 318,000 health apps are currently available, and according to a national survey, 65 percent of smartphone users downloaded at least one health app and used it daily.

Politics Is Costing Lives by Delaying Right-to-Try Legislation

A little over a week ago, I wrote a piece addressing some common misunderstandings and misleading arguments against recent federal right-to-try legislation. Since that short time ago, it seems countless articles expressing more confused ideas and misleading criticisms have made their way into major media outlets.

The legislation they are attacking is Senate Bill 204. The bill would enable terminally ill patients to access experimental drugs without the FDA’s approval. Patients could receive access with the help of their doctor, consent from the drug producer, and approval by their state government approval. If passed, Senate Bill 204 would provide a decentralized method to prolong the lives of the terminally ill.