Invoking the Defense Production Act: A Missed Opportunity to Address Medication Shortages and Border Security
Photo Credit: Go Nakamura/Reuters
On November 27, 2023, The Biden Administration invoked a national emergency-style act but not for what you might imagine. If you were hoping that somehow the so-called leaders of the United States were finally hit over the head with a magic wand to realize the magnitude & reality of the dire situation taking place with hundreds of thousands of migrants crossing our borders every month, sorry. No dice. Instead, The Biden Administration has chosen to invoke the “Defense Production Act (DPA) of 1950 to make more essential medicines in America and mitigate drug shortages.”
As part of this action, the Biden Administration announced “…nearly 30 new actions to strengthen supply chains critical to America’s economic and national security” through a creation of a Council on Supply Chain Resilience. The DPA was last invoked in 2021 as a means to expand access to protective equipment such as ventilators and masks during the medical ‘crisis’.
When have you ever known a government ‘task force’ or ‘council’ to be really effective at anything, especially when it involves several complicated bureaucracies? The departments/agencies involved in the Council on Supply Chain Resilience will involve the following participants:
National Security Advisor
National Economic Advisor
Secretaries of Agriculture, Commerce, Defense, Energy, Health and Human Services, Homeland Security, Housing and Urban Development, the Interior, Labor, State, Transportation, the Treasury, & Veteran’s Affairs
The Attorney General
Administrators of the Environmental Protection Agency & the Small Business Administration
Directors of National Intelligence
Office of Management and Budget
Office of Science and Technology Policy
Chair of the Council of Economic Advisers
U.S. Trade Representative
Senior ‘officials’ from the Executive Office of the President
Other Agencies
We all know how difficult it is to get two people to work together, let alone 25+ people/organizations minimum.
Where Does America’s Pharmaceuticals Come From?
The United States relies on a global supply chain for pharmaceuticals, with ingredients and finished products coming from a variety of countries. The top three sources of pharmaceutical imports to the United States are China, India, and Mexico.
Active Pharmaceutical Ingredients (APIs)
APIs are the building blocks of pharmaceuticals. They are the complex chemicals that give drugs their therapeutic effects. The United States imports a significant amount of APIs from China, India, and other countries. In 2019, China accounted for 40% of the U.S.'s API imports, India accounted for 25%, and other countries accounted for 35%.
Finished Pharmaceuticals
Finished pharmaceuticals are the final products that are dispensed to patients. The United States also imports a significant amount of finished pharmaceuticals from China, India, and other countries. In 2019, China accounted for 11% of the U.S.'s finished pharmaceutical imports, India accounted for 32%, and other countries accounted for 57%.
Why did the United States Outsource so Much of its Pharmaceutical Industry?
There are several reasons why the United States relies on a global supply chain for pharmaceuticals. These reasons include:
Lower labor costs: Manufacturing pharmaceuticals is a labor-intensive process. Countries with lower labor costs can produce pharmaceuticals more cheaply than the United States.
Access to specialized expertise: Some countries have specialized expertise in certain aspects of pharmaceutical production, such as the synthesis of APIs.
Economies of scale: When pharmaceutical companies manufacture drugs in large quantities, they can achieve economies of scale that make their products more affordable.
While I’m very confident the United States can supply the specialized expertise to carry the market for pharmaceutical production, domesticating our medications may mean substantial cost increases for our already astronomically-priced drugs. In addition, the time & investment by the United States government to realize the economies of scale required, may take decades. Let us also consider the mark-up in pharmaceuticals that the United States consumer is already subjected to:
According to a 2019 study by the Kaiser Family Foundation, brand-name prescription drugs in Mexico were, on average, 59% cheaper than in the United States. Generic prescription drugs were also cheaper in Mexico, with an average price that was 30% lower than in the United States.
Mexico has set price controls on medications & has less restrictive patent laws than the United States, which allows for more competition and lower prices for generic drugs
I’m not saying the United States shouldn’t be domesticating pharmaceutical production, but the government is focusing on only the key starting materials, specifically for sterile injectable medicines.
HHS has identified $35 million for investments in domestic production of key starting materials for sterile injectable medicines.
Latest Shortages on the FDA’s Drug Shortage List as of 28 November 2023
While sterile injectable medicines are critical, these are the major medications currently in critical short supply in the United States:
As of October 4, 2023, there are 329 drugs on the FDA's drug shortage list. These drugs are in short supply because of various reasons, including manufacturing problems, raw material shortages, and discontinuations. Some of the medications that are currently in critical short supply in the United States include:
Acetylcysteine: This medication is used to treat acetaminophen overdose and to help thin mucus in the lungs.
Activated charcoal: This medication is used to treat accidental poisonings and drug overdoses.
Acyclovir: This medication is used to treat viral infections, such as herpes simplex and chickenpox.
Adenosine: This medication is used to treat irregular heartbeats.
Albuterol: This medication is used to treat asthma and chronic obstructive pulmonary disease (COPD).
Amiodarone: This medication is used to treat irregular heartbeats.
Amoxicillin: This medication is a common antibiotic used to treat a variety of infections.
Atropine: This medication is used to treat a variety of conditions, including bradycardia, eye spasms, and nerve agent poisoning.
Baclofen: This medication is used to treat muscle spasms.
Cefotaxime: This medication is a broad-spectrum antibiotic used to treat a variety of infections.
Ciprofloxacin: This medication is a fluoroquinolone antibiotic used to treat a variety of infections.
Cyclosporine: This medication is used to suppress the immune system, which can be helpful in preventing organ rejection after transplantation.
Dextromethorphan: This medication is used to treat coughs.
Dopamine: This medication is used to treat low blood pressure and shock.
Epinephrine: This medication is used to treat a variety of emergency conditions, including allergic reactions, asthma attacks, and cardiac arrest.
Furosemide: This medication is a diuretic used to treat high blood pressure, heart failure, and kidney disease.
Heparin: This medication is a blood thinner used to prevent and treat blood clots.
Hydralazine: This medication is used to treat high blood pressure.
Hydrocortisone: This medication is a corticosteroid used to treat a variety of conditions, including inflammation, allergies, and autoimmune diseases.
Insulin: This medication is used to treat diabetes.
Levetiracetam: This medication is an anticonvulsant used to treat seizures.
Lidocaine: This medication is a local anesthetic used to numb an area of the body before surgery or other procedures.
Methylsalicylate: This medication is a topical pain reliever used to treat muscle aches and pains.
Morphine: This medication is a powerful opioid pain reliever used to treat severe pain.
Norepinephrine: This medication is used to treat low blood pressure and shock.
Ondansetron: This medication is used to treat nausea and vomiting caused by chemotherapy or surgery.
Phenobarbital: This medication is a barbiturate used to treat seizures.
Potassium chloride: This medication is used to treat low potassium levels in the blood.
Propofol: This medication is a general anesthetic used to induce and maintain anesthesia during surgery.
Ranitidine: This medication is a histamine H2 blocker used to treat heartburn and ulcers.
Sodium bicarbonate: This medication is used to treat a variety of conditions, including metabolic acidosis, kidney stones, and cardiac arrest.
Succinylcholine: This medication is a muscle relaxant used to facilitate intubation during surgery.
Tracheal tubes: These are tubes that are inserted into the trachea to help people breathe.
Vancomycin: This medication is a glycopeptide antibiotic used to treat serious infections that are resistant to other antibiotics.
Of the above listed medications the FDA has listed in critical shortage in the United States, only several are commonly injected as a method of dosing. I have observed many shortage reports to include the following:
Saline is low or on back order at medical supply companies
Paramedics are having to make their own epinephrine
43 reported cases in Australia of people infected with bacterium Ralstonia from tainted sodium chloride saline solution products from India & Greece
“No doctor was willing to prescribe me more than 7 days of antibiotics for a condition that normally requires a 3-4 week course of treatment.”
“All of our sterile saline was recalled and we can’t get any right now.”
“We are having a major shortage of Budesonide which is used in nebulizers.”
“My husband had a tooth pulled & was given prescription for pain killer. CVS couldn’t fill, ‘said’ had not been able to get for couple months.”
Key Starting Materials for Sterile Injectable Medicines:
Active pharmaceutical ingredients (APIs): These are the drugs themselves. They come in a variety of forms, including powders, liquids, and solids.
Excipients: These are inactive ingredients that are added to APIs to improve their stability, solubility, and bioavailability. Some common excipients include water, ethanol, propylene glycol, and polyethylene glycol.
Containers and closures: These are the materials that the sterile injectable medicines are packaged in. They must be made of materials that are compatible with the APIs and excipients, and they must be able to withstand the sterilization process.
Water for injection (WFI): This is a high-quality water that is used to prepare sterile injectable medicines. It must be free of pyrogens, endotoxins, and other contaminants.
A hospital pharmacist commented that sterile injectable medications are commonly used in “trauma care, as in wartime hospitals and combat medics.”
254 lbs. of Fentanyl Hidden Under Cucumbers Seized in Nogales - Photo Credit: AP
Meanwhile, How Much Illegal Drugs are Smuggled Across U.S. Borders Each Year?
The U.S. Drug Enforcement Administration (DEA) estimates that the value of all illegal drugs smuggled into the United States each year is between $180 billion and $320 billion.
Not only do we have a migrant crisis in the United States, drug-carrying mules are trafficking marijuana, cocaine, methamphetamine, heroin, & fentanyl in massive quantities worth triple digit billions each year.
The Illegal Drug Epidemic in the United States
According to provisional data from the Centers for Disease Control and Prevention (CDC), there were 111,355 drug overdose deaths in the United States in the 12-month period ending in April 2023. This represents a 10.5% increase from the 12-month period ending in April 2022.
The majority of drug overdose deaths in 2023 involved synthetic opioids, such as fentanyl, which were responsible for 71,293 deaths. This represents a 12.6% increase from the previous 12-month period. Other drug overdose deaths involved stimulants (31,102 deaths), cocaine (28,517 deaths), and benzodiazepines (20,416 deaths).
Consider the Cost of Drug Rehabilitation Programs to the U.S. Taxpayer
The total cost of drug rehabilitation in the United States is estimated to be between $57 billion and $75 billion per year.
A $35 Million Drop in the Bucket
While I agree that we need to do as much as possible to bring back manufacturing of all kinds to the United States, throwing a measly $35 million down a convoluted hole of bureaucracy is the not right answer toward protecting our pharmaceutical supply chain. Especially considering the aforementioned costs of illegal drugs entering the United States & the other parts of the Biden Administrations’ 30 actions:
$275 million in grant selections for the Department of Energy’s Advanced Energy Manufacturing & Recycling Grant Program
$196 million in investments by the USDA to strengthen domestic food supply chains & “create more opportunity for farmers and entrepreneurs in 37 states and in Puerto Rico in diversified food processing, resilient agricultural markets, & fertilizer production.” Meanwhile, if the Department of Agriculture detects one case of avian influenza on a farm, the farmer & end consumer are screwed!
8.1 million birds have been killed on commercial poultry farms this year with flock in Ohio among 5.8 million being killed this month the AP reported. What is the average cost of 8.1 million birds?
As of November 28, 2023, the average price of a broiler chicken in the United States is $0.63 per pound. Based on this price, farmers could get approximately $5,163,000 for 8.1 million chickens.
Unknown amount of money to be spent by the Department of Defense to ‘build’ on the $714 million in Defense Production Act investments already made in 2023 to support defense-critical supply chains to create a National Defense Industrial Strategy (NDIS).
The same White House press release stated “The Administration continues to deepen engagement with allies and partners to strengthen global supply chains” & reveals the United States is already working with Australia, Canada, the European Union, Japan, the United Kingdom, & the World Health Organization on drug shortages:
The Global Regulatory Working Group on Drug Shortages, currently chaired by the U.S. Food and Drug Administration, meets quarterly to discuss product shortages participating jurisdictions are encountering and ways such shortages are being addressed.
The United States already has The Global Regulatory Working Group on Drug Shortages, yet we still have 329 drugs on the FDA Drug’s Shortage List. Clearly, this ‘Working Group’ isn’t working.
May I remind you our government is already broken & deeply in debt?:
The Biden Administration needs to address the actual drug shortage, migrant crisis, & supply chain issues head-on. Americans don’t need a fancy press release, the government to invoke a Cold-war era act for increased spending & control, or throw more money at already failing attempts.
We can also ask the question, why not work closer together with Mexico & India (which we have a much less likelihood of going to war with) which already produce much of our pharmaceuticals instead of countries that are in the same boat as the United States? At the very least until the United States actually gets its act together with domesticating pharmaceutical production.
In addition, the United States should already be working with Mexico to combat illegal drug trafficking & human trafficking across our southern border.
What can my Fellow Warriors do About it?
Reduce or Eliminate the Reliance on Prescription Medications altogether. This may be done in some cases via proper diet, regular exercise, & supplementation with natural vitamins/herbs.
Ask your Doctor for an Emergency Supply - Work with your doctor & ask him/her to provide you with an emergency 30-90 day supply of your essential medications. I know this may not be possible with certain controlled substances but it doesn’t hurt to express your concerns & inquire. Especially if your medication is on the FDA Drug Shortages List.
Aquire Antibiotics Before You Need Them - Consider a telemedicine company like Contingency Medical to acquire emergency antibiotics before you actually need them. This way you are prepared with telemedicine doctor support to begin treatment right away instead of having to search endlessly for a pharmacy that has your prescription in stock.
Build Your Natural Immunity - I cannot stress this enough. Especially considering this new Chinese ‘flu’ mystery that is now circulating with its first U.S. cases being detected in Washington D.C. Consider adding the following to your daily supplementation regiment:
Until next time my fellow Warriors, stay informed, stay vigilant, Ever Forward!