Drug Shortages Potential Causes Stricter FDA, Price Controls and Policies Against Newer Medications

Over the past two years shortages have developed for over 180 drugs, including cancer treatments. According to a recent article written by Robert Goldberg, vice president of the Center for Medicine in the Public Interest, “the shortfall is the result of stricter Food and Drug Administration (FDA) regulation, government price controls on already discounted but complex drugs, and policies that discourage the use of new medications.”

Goldberg explained that, “companies, facing lower prices, tighter regulation and increasing government control over what drugs will be used and when, are exiting the U.S. market and investing in product development in China and India where, sadly, it is easier and cheaper to produce next-generation medicines.”

He added that, “stockpiling will only add to people’s suffering by replacing market reforms with government micromanagement. Government planners require months, if not years, to produce regulations, bids and supply estimates that are usually overgenerous to compensate for paltry prices. Government bungling was behind the failure of the smallpox and H1N1 vaccine program and responsible for billions of dollars in flu vaccines and antibiotics being dumped. The same forces pushing stockpiling also believe commercializing medical discoveries is evil.

Consequently, Goldberg asserted that, “the drug shortage is a product of a more troubling trend.” At a time when medical research could yield breakthroughs in the treatment of obesity, Alzheimer’s, diabetes, and stroke, among others, he maintained that, “innovation has all but dried up.”

Most of the medicines being used today were developed 30 years ago. Most of them have generic competition. They have contributed greatly to increased wellbeing but, as the return on generic drugs fall, price controls and regulation have created shortages. As a result, Goldberg asserted that, “Obamacare is making the commercialization of newer drugs and devices more difficult.”

Though new and faster methods to determine a technology’s safety and effectiveness exist, Goldberg argued that, “Obama’s FDA still demands evidence collected with science and statistical methods developed in the 19th century.” To emphasize this point, Goldberg noted that while “in the last two years, new medicines for AIDS, cancer, lupus and hepatitis have been developed, these products should have been available sooner if not for FDA nitpicking.”

Although the drugs are finally approved, patients are finding it next to impossible to access several new drugs and genetic tests that would transform the quality of life and extend survival for such illnesses as lupus, prostate cancer, and organ transplantation.

For example, Goldberg pointed to Provenge, the first cancer vaccine, which stalled at the FDA for years. Once approved, it faced 18 months of additional delay while the Obama administration figured out whether to pay for it. Goldberg asserted that, “the gauntlet cancer patients face with Provenge is being extended to everyone waiting for a medical breakthrough under Obamacare.”

Additionally, Goldberg pointed out that, “before a medical innovation can be used or paid for, the government will now demand additional research demonstrating that a new product will be more effective and cheaper than existing technologies. Since most new products come from small start-ups with limited cash, such a requirement means life-saving innovations will not be available at all.”

Moreover, he noted that, “before the cancer drug shortage there was the decision that women under 50 should not get mammograms. Both Provenge and Benlysta, new treatments for prostate cancer and lupus respectively, are hard to come by because of uncertainty about reimbursement by health plans and government.”

Ultimately, Goldberg maintained that, “the death and suffering flowing from such delays are the result of policies promoted by those who want to use the FDA and increased government control over medicine to slash access to new technologies.” He added that, “the shortage of old drugs is simply one side effect of this malevolent strategy.”

In the end, Goldberg asserted that, “no one in America should go without medicine because they can’t afford it and this shouldn’t be a nation where people are denied treatments because their government makes medicine impossible to produce or obtain.”