New drug importation policies in US could put patient health at risk

The escalating problem of high drug prices in the US has prompted President Trump to take steps towards providing people with more affordable prescription drugs. In December 2019, the presidential administration has published the new importation policies that aim to solve this long-standing problem. Currently open to expert commentary and public comment, the importation policies are based on the framework proposed by the and the FDA.

Americans are well aware that in neighboring Canada, as well as Europe and almost any other country, many prescription medicines are available at lower prices. points out that the state is involved in price regulation for essential medicines, people generally have to spend less on drugs. The lack of state regulation and competition between manufacturers in the United States have been fueling the situation in recent years. In 2019, average drug costs rose to $1200 per year, continuing to occupy the highest position in the world. At present, cancer drugs are costing patients about $10 000 per month. Not surprisingly, a survey conducted in October 2019 showed that the public for the most part approves drug importation from licensed Canadian pharmacies — almost 80% favors import allowance.

Experts agree that importing drugs will help bring competition to the market and solve the problem of high prices. After working through a two-part plan, the presidential administration claims that such imports will not only help gain access to more affordable prescription drugs, but will be both safe and clinically effective. In essence, the claims to be able to control manufacturing safety even outside the United States.

Why importing drugs can be dangerous?

Access to affordable prescription drugs is critical, but it must be done in a way that does not jeopardize public health. The United States has a rich history of illegal import of sub-quality drugs, the use of which ended tragically for many.

Strict regulations regarding the manufacture of drugs in the USA ensure the highest quality and safety of drugs on the market. In a number of countries, especially such active exporters as India and China, the quality standards are lower and the medicines produced there cannot compete with local ones in terms of quality. For this reason, until now drug importation remains mostly illegal, although in fact many people resort to buying prescription drugs abroad in order to save money, at their own risk.

Therefore, drug importation must be accompanied by serious safety measures, controlling the whole supply chain in order to avoid fake, life-threatening or ineffective drugs getting into the market. Those behind the new importation policies are certain that the proposed scheme will become the first successful program to supply the market with cheaper medicines from abroad.

The new rules will allow to import a number of drugs from Canada

The new policy developed by the Trump administration in cooperation with the FDA and HHS will allow to import some prescription drugs from Canada. Drug importation from other countries will probably not be provided since careful quality control will be difficult, if not impossible.

In fact, the Medicare Act of 2003 has already made the necessary amendments to allow the import of drugs from Canada. However, this right was never exercised, since the criteria for importing drugs could not be satisfied.

Currently the Office is preparing new regulations for the industry, which set out procedures for simplifying the import of prescription drugs, including biological products approved by the Office, produced abroad and approved for sale in other countries.

This announcement can be seen as the first step towards introducing the provisions of federal law, which will allow importing drugs from Canada under certain conditions. On the one hand, such imports should lead to lower prices for consumers, but at the same time, it is necessary to exclude the possibility of low-quality drugs entering the market.

Under the initiative, states and other government agencies at the non-federal level will be able to apply to the Office in order to obtain permission to import certain drugs. A number of pre- and post-importation measures will have to be followed in order to obtain the permission. Safety tests will be conducted to ensure that the drugs meet current standards, and the labels will have to be changed in accordance with the FDA requirements. Additional instructions are also recommended to help pharmacists work with new drugs. The question remains whether these measures will be sufficient to protect consumers from unsafe drugs coming from abroad.

Medicines imported under the new scheme can be obtainable in various ways, including licensed pharmacies, hospitals and other medical institutions.

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