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Six Executive Orders That Could Shake Big Pharma—and Protect Natural Health

Six Executive Orders That Could Shake Big Pharma—and Protect Natural Health
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A slew of recent Executive Orders quietly crack open Big Pharma’s monopoly, chip away at anti-competitive regulations, and defend Americans’ right to choose low cost options, including generic drugs and safe and effective natural health products.

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THE TOPLINE

  • Some of the orders attack runaway drug prices by tying US costs to the lowest prices abroad, fast-tracking generics and biosimilars, and re-classifying certain pricey brands as over-the-counter.
  • Others tell agencies to catalog and kill any regulation that creates de facto monopolies or stretches statutory authority—targets that include FDA and FTC policies that sideline supplements through onerous pre-approval and clinical-trial demands.
  • Another order bars federal pressure to censor lawful speech, bolstering ANH efforts to let companies share truthful, science-backed claims about nutrients and natural remedies—an essential step toward a genuine right to rely on nature for health.

How many more headlines about record-shattering drug profits will it take before we admit the system is rigged? We could be a healthier nation and save billions in healthcare costs by embracing natural medicines. Instead, we have a system that has become completely dominated by Big Pharma and its government allies, one where disease treatment and prevention is the sole preserve of dangerous, expensive, often ineffective and often dangerous pharmaceutical drugs. The result? Record rates of chronic disease.

Yet several Executive Orders from the Trump Administration crack open the door to a different future. They challenge the price-gouging, dismantle the barriers that keep natural remedies in the shadows, and demand that bureaucrats stop twisting the law to protect corporate fiefdoms. We’re working on a number of exciting initiatives to leverage these actions into victories for the millions of Americans that wish to opt for natural health.

“We now have a rare opportunity to push back against Big Pharma’s dominance—built on anti-competitive practices, excessive regulation of natural products, distorted science, and censorship of truthful health information,” said ANH Executive Director, Rob Verkerk, PhD. “At ANH,” he continued, “we’re launching a raft of legal and regulatory actions that draw on executive orders, constitutional protections, legal precedent, and transparent science to help restore balance to our healthcare system.”

While commentators debate the broader political implications of the many actions taken by the Trump Administration over the last few months, our lens is simple: do any of these Executive Orders open doors for Americans to choose natural health options? If so, which ones? The answer, judged strictly on the text of some of these orders, is ‘yes’.

We’re cognizant of the polarized political climate we live in, but as ever, ANH is laser-focused on our mission and core principles: that is, fighting for everyone’s freedom to choose natural options to stay healthy. Whether Democrats or Republicans are in office, we look for opportunities to advance those goals.

OrderWhat it does
EO 14212Establishing the President’s Make America Healthy Again CommissionEstablishes the President’s Make America Healthy Again Commission, creating a high-level federal task force to investigate and combat the alarming rise in chronic diseases—especially among children—by addressing root causes such as poor nutrition, environmental toxins, over-medication, and lack of transparency in health research.
EO 14297 – Delivering Most-Favored-Nation Prescription Drug Pricing to American PatientsDirects HHS, FDA and the US Trade Representative to peg US drug prices to the lowest price paid in peer nations and to permit drug importation. If no progress is made, the order directs HHS to pursue rulemaking to impose Most Favored Nation drug pricing.
EO 14273 – Lowering Drug Prices by Once Again Putting Americans FirstOrders increased transparency for the Medicare Drug Price Negotiation Program, improvements for Medicare’s ability to obtain better value for high-cost drugs, accelerated approvals of generic and biosimilars, and an FDA plan to “re-classify” expensive brand drugs as OTC drugs.
EO 14267 – Reducing Anti-Competitive Regulatory BarriersTells every agency to catalog and then repeal rules that create de facto monopolies or “unduly limit competition,” including licensure rules.
EO 14219 – Ensuring Lawful Governance & the “Department of Government Efficiency” Deregulatory InitiativeRequires agencies to identify and mothball rules that are unconstitutional, lack clear statutory authority, or rest on expansive “Chevron-style” interpretations, among other things. Enforcement resources must be de-prioritized for such rules.
EO 14149 – Restoring Freedom of Speech and Ending Federal CensorshipProtects Americans’ free speech rights by stopping the federal government from pressuring or working with others—like social media companies—to censor speech.

The Emerging Themes—And Why They’re Game-Changing for Natural Health

Taken together, a clear picture starts to emerge. These Executive Orders chip away at Big Pharma’s price gouging and monopolistic practices while opening the door to more competition from the natural products sector.

1. Whittling away Big Pharma monopolies

EO 14297 and EO 14273 strike directly at monopoly prescription drug prices. Allowing Big Pharma to charge exorbitant prices for drugs while also censoring information describing the healing power of food and supplements that are alternatives to those drugs is a crony capitalist double-whammy. These executive orders represent an encouraging first step toward loosening Big Pharma’s grip on the market by hitting them where it hurts: their pocketbooks.

2. Rolling back anti-competitive rules

EO 14267’s mandate to list and rescind rules that “create, or facilitate the creation of, de facto monopolies” is tailor-made for the government’s multi-pronged effort to tilt the scales in favor of Big Pharma at the expense of natural medicine.

For example, the FTC has been trying to force supplement companies to fund full-scale RCTs before making truthful health claims—an impossibility for non-patentable nutrients. It is a backhanded way of censoring many truthful health claims, depriving Americans of vital health information. ANH is already fighting back against this censorship with our recently-filed petition to the FTC demanding the removal of these absurd standards. If proven benefits cannot be communicated to consumers, food and supplements are at an incredible competitive disadvantage to drugs which alone can claim to treat or prevent disease.

Another crucial instance of anti-competitive regulations is the “drug preclusion” clause—what we at ANH have labeled the “back-channel” at the FDA that allows drug companies to turn supplements into drugs. For supplements that are considered “new” under the law—that is, they weren’t sold “in or as a supplement” before 1994—companies must submit a notification to the FDA with studies to prove that it is safe before that ingredient can be marketed (more on this below). But if a drug company files an investigational new drug application (IND) and studies that ingredient before the FDA receives an NDI notification on it from a supplement company, it can no longer be sold as a supplement. This creates a stacked deck in favor of Big Pharma monopolies. Several important supplements have been threatened or eliminated in this way, including pyridoxamine, CBD, and NMN.

Other anti-competitive government measures include the FDA’s war on homeopathy and compounded medicines, including compounded bioidentical hormones and bioidentical peptides.

3. A tool to rein in FDA overreach after Chevron

Executive Order 14219 tells every federal agency to drop any rule that isn’t the “best reading” of the law—language that arrives as the Supreme Court has scrapped Chevron deference, the doctrine that once let agencies stretch statutes with little push-back. Together, these shifts give natural-health advocates a powerful lever against government overreach.

A critical example of this kind of overreach is the FDA’s 2016 draft guidance on “new dietary ingredients” (NDIs). ANH has contended for years that the FDA’s guidance creates a de facto pre-approval system for “new” supplements that is not in accordance with the law, requiring expensive safety studies and the creation of extensive dossiers on new ingredients. This represents a major barrier to market entry that most supplement companies simply cannot afford—the complete antithesis of the Dietary Supplement Health and Education Act of 1994’s plain and intended meaning, which aimed to expand, not restrict, access to supplements. 

Further, we’ve argued that the FDA has misapplied the law to widen the number of products subject to NDI rules while narrowly interpreting the exemptions.

All told, experts estimate that the FDA’s NDI requirements would lead to the elimination of over 41,000 supplements from the shelves.

By reining in the FDA’s anti-supplement interpretations, these legal shifts could further help dismantle the pharmaceutical monopoly over medicine and protect consumers’ access to affordable, science-backed supplements.

4. Re-opening the information pipeline

Executive Order 14149’s protections for free speech—especially when considered alongside the above-mentioned directives eliminating anti-competitive practices and excessive federal regulation—align closely with ANH-USA’s forthcoming petition on “authoritative statements.”

This initiative calls on the FDA to follow Congress’s 1997 mandate requiring that truthful, government-backed statements about nutrient-disease relationships be permitted on product labels and in advertising. Although the law allows supplement companies to use such statements to better inform consumers about the benefits of nutrients, the FDA has routinely blocked these claims in practice in direct violation of the statute.

When the White House says agencies may not suppress lawful speech, it strengthens the petition’s constitutional footing. Stay tuned for more details on this exciting project.

ANH General Counsel Jonathan Emord said, “The Executive Orders and Executive Memoranda compelling the agencies to abandon protectionist practices, open markets, and defend individual liberties are welcome and unprecedented, but there is so much to be done. Bureaucratic intransigence, the limits of power, and a timetable now of less than four years reveals these extraordinary measures to be not enough. Consequently, the battles for freedom, including freedom of informed choice, will depend on court victories, petitioning for changes in rules, and drafting and urging passage of new legislation atop the official measures from the White House. That’s where ANH plays a unique and indispensable role.”

Toward A Fundamental Right to Rely on Nature

Every American should enjoy the right to choose food‐ and nutrient-based strategies for health. By attacking monopoly pricing, dismantling anti-competitive regulatory moats, rescinding unlawful rules, and protecting truthful speech, these orders collectively nudge US policy toward recognizing that right.

ANH-USA has many irons in the fire at the moment to leverage these EO’s into tangible natural health victories. We will keep you updated on the latest developments.

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