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New US President Donald Trump has not been shy about his plans for the US Food and Drug Administration (FDA), promising to dramatically decrease the amount of time it takes to issue approval for new drugs, slash regulatory authority by forcing agencies to cut two regulations each time a new one is issued, and institute a federal hiring freeze that, whether intentional or not, would have a significant impact on how quickly the FDA can respond to these new requirements.
The FDA’s existing authority over prescription drug regulation is a known entity – and pharmaceutical companies are reacting with mixed approval to some of the President’s ideas (tax relief for drug manufacturers and cutting federal regulations: good; gutting an agency that pharmaceutical companies view as crucial in making sure drugs are both safe and effective: bad). But when it comes to over-the-counter (OTC) drugs that are outside the purview of the FDA, what can we divine from the President’s statements that might affect the world of consumer health beyond prescription drugs?
There are three main policy levers through which the FDA can impact over-the-counter drugs: direct-to-consumer (DTC) advertising, warnings for harmful medications, and the switch of drug status from prescription to OTC.
The United States is one of only three countries in the world that allows DTC advertising for RX drugs (the others being New Zealand and Brazil). The FDA heavily regulates the control of DTC advertising through its Division of Drug Marketing, Advertising, and Communications (DDMAC), which approves advertisements based on their accuracy about what the medication does and does not do, whether the advertisement is presented fairly, and whether there is a demonstrated balance in the advertisement between the drug’s benefits and its side effects. While the vast majority of DTC advertisements in the U.S. are for prescription drugs, drug companies also invest heavily in marketing their OTC medications, which is much easier to do since OTC medications are not subject to any FDA regulations and are instead overseen by the Federal Trade Commission (FTC), like all other non-health products like appliances, apparel, or cars. Importantly, while the FTC does require “a reasonable standard of truthfulness,” it does not require advertisements to list dosage requirements or side effects, a fact which many consumer advocates blame for the recent increase in overdoses of common OTC painkillers like acetaminophen (Tylenol) and ibuprofen (Advil).
So what potential impact could a President Trump’s FDA have on DTC advertising for OTC drugs? Probably not much, but if regulations are indeed slashed as dramatically as the President intends, it is entirely possible that we could see an increase in DTC advertising overall as well as fewer harmful effects being mentioned alongside the drugs’ benefits.
The OTC Drug Team at the FDA’s Office of Compliance monitors the OTC drug market to ensure that all drug products are safe and effective. When they receive an alert or an inquiry about a medication from a member of the public, they can issue any number of responses from warning letters and inspection requests to recommendations for the drug’s recall or seizure and criminal sanctions against the manufacturer. With an estimated 300,000 OTC drugs available in the U.S. and more being introduced every day from foreign markets, the OTC Drug Team is under a great deal of pressure to review these products and approve them before they are marketed to the general public. It’s not a fast process, and one about which that the FDA is adamant on being methodical and systematic to avoid any medications reaching the market that are either unsafe or dishonest in their labelling, ingredient information, and dosage recommendation. If the FDA is further downsized in terms of funding and staff under the Trump administration, it seems likely that the time it would take for foreign-made OTCs to be approved for sale in the U.S. will be longer and the agency will be less equipped to respond to public inquiry in the case of unsafe drugs already on the market.
The most significant way in which the FDA affects the consumer health industry is through RX to OTC switches, or the transfer of a medication from prescription to non-prescription status. When a drug switches to OTC status, it usually skyrockets in profitability as ease of access to consumers increases and cost decreases. While there is often intense pressure from pharmaceutical companies and the public for moving a drug to OTC status, the FDA traditionally takes around 10 months to do so, weighing input from medical experts, data on drug efficacy, and public comment to make their decision. Drug companies, on the other hand, lose their patents on medications after 3 years so are often rushing to get OTC status just as their patent approval runs out and they lose much of their profitability to competitors. The erectile dysfunction drug Cialis is about to hit this point and Sanofi is hoping to get FDA approval sell it over the counter in 2018 (under this agreement Sanofi would purchase the medication from manufacturer Eli Lilly).
So, here is one way in which a change in FDA policy could significantly impact the world of OTC medication: a dramatic reduction in regulation at the FDA means that more drugs may move from RX to OTC status and many new medications could enter the market with OTC status. This could have a major impact on sales of current OTC drugs, depending on what type of drugs they were. The specifics of these changes will depend a lot on Trump’s pick for FDA commissioner; we will have to wait and see what the new commissioner chooses to do, though signs are that this will be a highly regulatory-averse administration and will be moving quickly to institute a more streamlined drug switch process.
Finally, it is important to point out that while these scenarios are all domestic to the United States, changes in the regulatory structure for OTC drugs in the United States could mean significant changes for foreign drug manufacturers. The US is the largest OTC drug market in the world, grossing more than USD 26 billion in 2016, and if regulations are indeed lifted enough to allow greater competition within that market for foreign companies, it seems inevitable that more foreign manufacturers will begin looking for ways to get a share of that market.