The predetermined rule, which was issued on December 18 by President Trump along with the Department of Health and Human Services (HHS) and the FDA (Food and Drug Administration), offers exceptional circumstances that would “ensure the introduction poses no further risk to the public’s well-being and safety while performing a meaningful reduction in the cost of related products to the American customer,” according to the company.
New Terms Wanted
The draft direction places forth ideas for drug companies to present documentation confirming that the merchandise allowed for import from any foreign country is, in fact, an FDA-approved drug stock, including that it is manufactured following the FDA-approved administration.
States and specific other non-federal ministry entities will be able to submit admission program applications to the FDA for review and signature. “An admission program could be co-sponsored by a pharmacologist, a wholesaler, or another state or non-federal administrative entity,” the agency stated.
“Today’s publication outlines two pathways for the safe reception of certain medical drugs to help produce safe, efficient, more affordable medicines to American sufferers,” HHS Secretary Alex Azar announced. “These are historical performances by HHS and the FDA, and they realize the bold nature of President Trump’s plan for lowering drug prices.”
Nevertheless, ASHP is concerned about the security of imported drugs and doesn’t think the recommended rule will lower drug prices.
Since the size of the Canadian pharmaceutical business is only a small part of the US market, it is “nonsensical to maintain Canada will be a meaningful source of low-cost medicines,” Tom Kraus, JD, vice president of government connections for ASHP.
The key Security Conditions
“We need a bipartisan resolution to bring down drug payments for American sufferers. Transportation is not that resolution,” Kraus stated. “While the idea of pharmaceutical transportation may seem as simple as a US company making and sending drugs to Canada, for instance, and Americans buying them to be sent back to the US, the presence is more difficult. Importation conceivably short-circuits the security conditions that protect the American medicine stores and is questionable to result in meaning cost savings for the sufferers.”
ASHP has long been exposed to shipping drugs from Canada due to safety matters. “One of our main businesses with the safety of transportation is probably bypassing safety requirements intended to protect against contaminated or false prescriptions,” Kraus said.
Kraus guided to a 2016 National Association of Boards of Pharmacy study, which found that 96% of drugstores claiming to sell Canadian drugs are fake, so those pills do not enter the legitimate Canadian supply connection.
“We ought to not take these risks, especially when this method is unlikely to yield significant cost savings for patients,” he said.
Although NCPA officials pronounced they are still reviewing the proposed rule, Ronna Hauser, vice president of policy and management activities for NCPA (National Community Pharmacists Association), said that they do not see anything that “would make us feel more satisfied” with the least conditions for admission.
NCPA infringes any transportation proposals that do not meet several minimum requirements for independent community pharmacies, including:
- An introduction plan shall permit small company community drugstores to acquire prescription drug products from a foreign wholesaler or manufacturer at competitive prices not currently available in today’s US supply chain.
- An importation program shall require such a product that is acquired from a foreign wholesaler or manufacturer to comply with US federal labeling and quality requirements. “For example, the product must comply with the Drug Supply Chain Security Act (DSCSA) in that the product must have a unique product identifier, and trading companions must provide traceability data.”
- Given the quality of DSCSA-compliant distribution channels, an import program shall not permit customers from acquiring prescription medicine products from a foreign object.
- Given the vast advantages of brick and mortar stores to promote patient’s medication adherence and battle product waste, an admission program “shall utilize the existing structure of the US pharmaceutical stores chain to dispensing prescription drug products,” NCPA stated.
- An introduction plan shall not impose an additional financial burden on small business association stores. For instance, product labeling under the DSCSA is the sole liability of upstream trading partners, not the dealer.
- An importation business shall support full access to prescription medication products and also encourage consumer choice of where to purchase such prescription drug product at the pharmacy level.
- An importation program should not subject short business agreement drugstores to rigorous accreditation and licensing requirements outside of those requirements already currently identified by state and federal law.
Comments on the proposed rule are being accepted for 75 days after publication in the Federal Register, and comments on the draft guidance are being accepted for 60 days after publication in the Federal Register. Let’s expect the possible consequences and upcoming changes in 2020.