FDA Reform: Cherry Pies, Antibiotic Delays, Medical Device Regulations

[Updated April 30 with new title, notes on Google searching, and links from FDAReview.org]

The Food and Drug Administration (FDA) has attracted a wide range of critics. Some criticize FDA regulation of cherries in frozen cherry pie (see Right now, frozen cherry pies must be 25% cherries, no more than 15% blemished. The FDA wants to cut obscure rules. Chicago Tribune, April 19, 2019).

Other critics warn that millions may soon die because antiquated FDA testing regulations slow and block the approval of new antibacterial drugs for microbes gaining resistance to past antibiotics. For an overview see Dept. of Existential Threats: Who’s Worried About Superbugs? (Inside Philanthropy, May 31, 2018):

…the Gates Foundation has been thinking for a while now about drug-resistant superbugs. It shares the fear of many experts that the rise of antibiotic-resistant bacteria poses a profound threat, both by jeopardizing the everyday workings of health systems and by increasing the risks of an unstoppable pandemic. 

Abstracts from journal article document regulatory problems. Emerging Resistance, New Antimicrobial Agents  …  but No Tests! The Challenge of Antimicrobial Susceptibility Testing in the Current US Regulatory Landscape (Clinical Infectious Diseases, July 1, 2016) notes in the abstract:

The ability of laboratories in the United States to effectively perform ASTs is challenged by several factors [some] are entirely man-made. These include unnecessarily strict US Food and Drug Administration (FDA) limitations on how commercial AST systems can be used for diagnostic testing, the absence of up-to-date performance data on these systems, and the lack of commercially available FDA-cleared tests for newer antimicrobial agents or for older agents with updated breakpoints. 

See also Dry antibiotic pipeline: Regulatory bottlenecks and regulatory reforms (Journal of Pharmacology & Pharmacotherapeutics, Jan.-Mar., 2014):

Only 2 new classes of antibiotics have emerged in the past 3 decades, namely, oxazolidinones (linezolid) and cyclic lipopeptides (daptomycin).[1] The antibacterial pipeline is scarce because of the costs associated with the development and licensure of antibiotics and the complexity of conducting clinical trials. … In this article, we attempt to discuss various regulatory bottlenecks in the development of novel antibacterial drugs. In the latter part of the article, we discuss various regulatory reforms that could improve novel antibacterial development.

THE ANTIBIOTICS BUSINESS IS BROKEN—BUT THERE’S A FIX (Wired, April 25, 2019) discusses the problems with antibiotic drug development and testing regulations beginning with reporting on “biotech company Achaogen announced that it was filing for bankruptcy.” (The article doesn’t seem to address reforming FDA regulations as much as propose pushing more money at companies developing and testing new antibiotics.”

The world is running out of useful antibiotics because the rise of antibiotic resistance in bacteria is undermining them, and big firms are disinclined to make more. In 2018 alone, three large legacy pharma firms closed their antibiotic research programs. So the collapse of even a small business that stepped up to make a new antibiotic is a blow.

It was strange searching with Google for recent articles critical of the FDA. Searches usually returned a dozen FDA publications on how the agency was now dealing with problems like approval delays and antibiotic resistance. The website FDAReview.org, a project of the Independent Institute, collects recent research, mostly critical of FDA regulations. Recent articles include:

• Right-to-try Laws Help Patient with Terminal Brain Cancer, (FDAReview.org, February 1, 2019)

• Let Competition, Not Politicians, Bring Insulin Prices Down (FDAReview.org, February 20, 2019)

• FDA Wants More Sunscreen Regulations, but Would Consumers Get Burned? (FDAReview.org, March 14, 2019)

• Deregulation Is the Only Cure for High Drug Prices, (FDAReview.org, January 3, 2019)

For an overview of how economists see food safety regulations, see Regulators Are Not What Makes Food Safe (AIER, December 4, 2018), which includes some history:

It’s one of the most puzzling claims of the pro-regulation ideology: food makers and sellers have a weak incentive to make sure their food is safe for consumption. The briefest look at the dynamics of this food panic reveals the opposite. Selling an unsafe product is catastrophic for industry. And yet it is nearly universally presumed that we would all be buying and consuming poisons daily were it not for food regulators in Washington who tell people how to keep food safe. They must stand ready to issue recalls, the thinking goes, else we would be doomed.

The myth was born in the early years of the 20th century, with Upton Sinclair’s The Jungle of 1904. It was fiction, but very compelling. The horrors of the meat-packing industry described therein (including scenes of workers falling into vats of boiling fat) inspired the first large-scale federal regulation on food safety: the Meat Inspection Act of 1906. Theodore Roosevelt saw this as a necessary first step “to do away with the efforts of arrogant and selfish greed on the part of the capitalist.”

Just as the Food and Drug Administration tries to regulate safety and efficacy, every state requires doctors have state issued medical licenses. States license public school teachers too. Having a state license however doesn’t insure capable doctors or teachers. Certification is a better approach to competency and safety. Clarifying the Difference Between Medical Licensure and Board Certification (Academic Medicine, January 12, 2016).

Many areas of FDA regulation could be reformed by debater’s affirmative cases. One of the easiest and most straightforward might be to separate FDA testing requirements for drug safety from efficacy testing. Trying to figure out how effective a new drug is turns out to be far more complicated and costly than making sure the new drug is safe in prescribed doses.

O’Neill has proposed that the FDA only require companies to prove drugs are safe before they are sold — not that they actually work.

Trump considers naming FDA chief who would radically overhaul the agency (Stat, December 6, 2016

Reactions to Trump FDA Chief Rumor: Unmitigated, and Unsupported, Fear of a Libertarian Planet (Reason.com, December 8, 2016) quotes advocates of FDA reform, noting:

Delaying access to new drugs kills people. As Competitive Enterprise Institute general counsel Sam Kazman has observed [PDF], “Whenever FDA announces its approval of a major new drug or device, the question that needs to be asked is: If this drug will start saving lives tomorrow, then how many people died yesterday waiting for the agency to act?”

Here is Cato Unbound post on the debate over reforming FDA regulations to expand “right to try” drugs. The Track Record of Right to Try and Why It Matters (Cato Unbound, July 31, 2017). Here is overview of four perspectives for the July 2017 discussion on The Ethics of Self-Medication.

The Foundation for Economic Education (FEE) has a great many articles on problems with FDA regulations here. Some titles sound like fun affirmatives to run with, for example: FDA Approval Should Be a Suggestion, Not a Requirement (FEE.org, January 4, 2018).

Not only does the FDA require extensive testing of medical treatments, but they exercise coercive power that prevents people from using non-FDA-approved drugs. Their use of coercion is not only immoral but has caused hundreds of thousands of deaths due to delayed availability of effective drugs.

The FDA’s regulations of medical devices has been under review, with Gottlieb Announces Medical Device Approval Process Update (Policy & Medicine, May 4, 2018) reporting:

FDA Commissioner Scott Gottlieb announced in a blog post the agency would be updating its medical device approval processes in order to accommodate rapidly advancing technologies. He described the modernization of FDA’s review framework would include the addition of a voluntary, alternative pathway for demonstrating substantial equivalence, and allow more flexibility to use modern criteria as the reference standard. Additionally, the new pathway will permit comparisons to standards that more closely approximate the kind of novel technology being evaluated.

A Wharton publication provides an overview in The FDA and the Regulation of Medical Device Innovation: A Problem of Information, Risk, and Access (February, 2016), beginning:

Innovative new drugs and medical devices are often available in other countries long before they arrive (or don’t) in the U.S., creating potentially frustrating access problems for U.S. citizens who would like to utilize these products but cannot due to the FDA’s approval process, which demands not only product safety but effectiveness.