Revisiting Florida’s Plan to Import Drugs from Canada

Posted by bryan hanley On October 23, 2024 at 11:07 am | Comments Closed

An FDA-Approved Plan with Major Implications

Earlier this year, the FDA authorized Florida’s proposal to import select drugs from Canada under section 804 of the FD&C Act. The law allows companies to import prescription drugs in bulk if doing so saves Americans money and doesn’t put the health and safety of Americans at risk.

According to the office of Florida Governor Ron DeSantis, the proposal will save the state an estimated $180 million annually. More specifically, this program will reduce the price the state pays for medications used by certain groups, including older populations, foster children, and incarcerated individuals. Florida will begin with importing small cases of chronic medication, including those treating HIV/AIDS, mental illness, prostate cancer, and urea cycle disorder.

The FDA has emphasized that for Canadian drugs to be imported into the US, Canadian partners and American companies receiving them must adhere to additional security requirements. These include specifying the drugs they plan on importing, verifying drug authenticity and compliance with FDA-approved specifications, and relabeling these drugs in accordance with FDA policy.

Not Everyone Sees the Potential Benefits

However, despite the cost-saving claims from Florida as well as the FDA’s approval of the change, many question the decision and the proposed benefits. Many experts believe this policy change will not solve the high-price issue of prescription drugs in the US. Critics argue the Canadian drug supply is too small, which means the change will not only have a minor impact on price reduction in the US, but could lead to major shortages throughout Canada. Four days after the policy change, the Canadian Government released the following statement:

“The Government of Canada is taking all necessary action to safeguard the drug supply and ensure Canadians have access to the prescription drugs they need and has been clear in its position: bulk importation will not provide an effective solution to the problem of high drug prices in the US.”

Accordingly, prominent members within the pharmaceutical industry have counteracted against the ruling; Stephen Ubl, President and CEO of Pharmaceutical Research and Manufacturers of America (PhRMA), believes the ruling has detrimental implications on American pharmaceutical supply chains. “The importation of unapproved medicines, whether from Canada or elsewhere in the world, poses a serious danger to public health,” Ubl claimed following the approval.

What Does this Mean for Compliance?

As to how these Canadian imports will comply with DSCSA Requirements, in particular Enhanced Drug Distribution Requirements, remains questionable. With Enhanced Drug Distribution Requirements delayed for connected trading partners in the US, will Canadian pharmaceutical manufacturers be expected to fully comply with DSCSA in November or will they be eligible for additional time for completion?

Is anyone aware of any Canadian pharmaceutical importation plans or activity since the policy change took effect in early January 2024? Have Floridians spent $50 million implementing the plan? If yes, how did that ‘investment’ benefit American patients? Since more states may adopt a similar policy in the future, understanding fiscal costs and benefits is essential.

Finally, though Canadian imports must meet additional drug security requirements, will counterfeiters see this policy change as a money-making opportunity? Considering the numerous instances of domestic counterfeiting, we can’t count this out as a possibility.

Beware of Counterfeit Ozempic, says FDA

Posted by bryan hanley On October 15, 2024 at 1:05 pm | Comments Closed

Authentic Ozempic needle side by side with a fraudulent needle

Counterfeiting: A Major Issue with Drastic Consequences

On October 2nd, the FDA released an article highlighting the risk of unapproved weight loss drugs, including semgalutide and tirzepatide. These drugs pose a major risk to patients due to their lack of quality assurance.

Illegally marketed versions of these drugs have infiltrated pharmaceutical supply chains, most notably, Ozempic. Counterfeit versions of the drug have been marketed as authentic, but could contain too much, too little, no active ingredient, or harmful ingredients. These illegal drugs pose a risk to consumers; in fact, according to a December 2023 report, 2 people died and three people were hospitalized after consuming counterfeit Ozempic.

Another DSCSA Delay

The FDA October 9th that they were delaying implementation of Enhanced Drug Distribution Security requirements, along with other requirements of section 582(g) of the Drug Supply Chain Security Act. This compliance extension would only be for trading partners who have made a documented attempt to complete data connections with immediate trading partners, or those who are already doing so.

The FDA has emphasized the decision came from a concern over potential drug supply shortages. In the release, the FDA referenced trading partners’ struggles “resolving issues involving missing or erroneous data in electronic DSCSA transaction information and transaction statements” without delaying product distribution (including those in shortage) downstream.

The concern for preventing supply shortages downstream is real. Preventing shortages can help minimize the risk of counterfeit products, given how shortages lead to higher rates of counterfeits as consumers are willing to pay higher prices for goods. However, what’s also important to consider is the reason behind creating Enhanced Drug Distribution Security (EDDS) requirements in the first place.

Counterfeit Crisis: DSCSA’s Role

The Enhanced Drug Distribution Security requirements under the DSCSA were created for instances like this. Counterfeiters have become increasingly deceitful in their craft: packages with authentic lot numbers and detailed inventory trails make it very difficult to determine the legitimacy of drugs. Sight alone is simply not enough to authenticate legitimate drugs from counterfeits, especially for end consumers—just look at the image above!

Enhanced Drug Distribution Security requirements drastically reduce this risk, mandating product-level traceability and interoperability. Flagging down counterfeit Ozempic is much easier to do with EDDS requirements in place; the FDA delaying these requirements again could pose risks similar to what we’ve seen with Ozempic.

While it’s essential to acknowledge the FDA’s commitment to preventing drug shortages, delaying EDDS requirements may bring about its own consequences.

HDA DSCSA Guidance

Posted by bryan hanley On October 9, 2024 at 12:36 pm | Comments Closed

Following the recent HDA Traceability Seminar between August 26th-28th, I had the opportunity to lead a conversation amongst dozens of pharmaceutical partners and solution providers; we discussed various important topics related to the DSCSA, from Waiver, Exception, and Exemptions, to Verification Routing Services, and more. Emphasizing the importance of transparency and open conversation, I thought I’d highlight some important insights.

It’s All About the Data

The FDA understands there are conflicts in terms of data quality and integrity. Downstream integrity is impossible without manufacturers ensuring their data and products align with updated standards. The FDA has stressed the importance of pharmaceutical partners, particularly manufacturers, meeting these standards by the end of the stabilization period (next month). However, for certain exceptions, including product/no data, WEEs must be considered.

Waivers, Exceptions, Exemptions

Since mid-June, there have been over 324 requests for package-level requirements WEEs, with more likely to be submitted as we approach the deadline. Dispensers are most frequently requesting WEEs, followed by wholesalers, manufacturers, and repackages. The issue many partners are experiencing is that downstream partners cannot get accurate data from suppliers without upstream partners providing it to them efficiently. The FDA believes it is adequately staffed to handle WEEs, and if they find consistent requests for handling WEE scenarios, they will announce how partners should handle them.

Easier Said than Done

Navigating the complexities of Waivers, Exceptions, and Exemptions is oftentimes easier said than done. While the FDA has provided various recommendations for handling tricky exceptions, oftentimes, partners still find themselves facing challenges in practice.

VRS on the Rise

VRS is gaining popularity as an effective means to ensure interoperability between supply chain partners, helping pharmaceutical partners conform to product identification and authorization requirements under the DSCSA. Apart from saleable returns for pharmaceutical partners, VRS can provide additional verification in medical emergencies, though it’s not intended to bypass EPCIS verification.

If you have any questions about these insights, please don’t hesitate to contact us.

Louisiana Board Report Sheds Light on DSCSA Compliance

Posted by bryan hanley On October 2, 2024 at 12:28 pm | 0 Comments

A survey conducted by the Louisiana Board of Drug and Device Distributors (published on October 1st) found that a majority of trading partners have the necessary electronic systems to exchange data with other trading partners under the updated DSCSA compliance standards. The survey was sent to designated responsible persons (DRPs) at facilities that distribute drugs to Louisiana between August 13th and September 23rd. The survey received a response rate of 273 different firms across 40 states and Canada.

According to the results, 77% of firms reported having processes in place for identifying suspect and illegitimate products, 75% have procedures in place for verifying products, and 74% have implemented data exchanges between partners. While the results of firms having policies for managing exceptions (45%), procedures for identifying ATPs (43%), and policies for managing WEEs (29%) didn’t indicate as strong of results, the significant majority of firms are taking the necessary steps to protect the integrity of our pharmaceuticals, and accordingly, to protect the health of consumers.

Executive director of the Louisiana Board of Drug and Device Distributors, George Lovecchio, believes the results of the survey withhold positive implications. Besides calling to action the importance of the policies and procedures that need to be in place for DSCSA, the results show that “we can make this November (DSCSA) deadline”, but can only “do it if we work together.”

Lovecchio added, “The survey shows that the time for excuses is over and it’s time for implementing (DSCSA guidelines).” For the integrity of our supply chains, trading partners failing to meet compliance requirements must prioritize their efforts.

FDA: No More Delay for Updated DSCSA Guidelines

Posted by bryan hanley On September 12, 2024 at 2:01 pm | Comments Closed

The FDA has reaffirmed its commitment to the November 27, 2024, deadline for pharmaceutical partners to adhere to upcoming DSCSA regulations. With time running out, pharmaceutical stakeholders must assess their readiness and address any outstanding challenges.

Ensuring accurate and complete data exchange between trading partners is critical for DSCSA compliance. Yet many partners remain unprepared to meet these guidelines.

Helping You Become Compliant

Gateway Checker offers comprehensive solutions to address the challenges of DSCSA compliance. We specialize in helping you assess whether your pharmaceutical transactions comply with upcoming DSCSA regulations.

Are you prepared for the DSCSA deadline? See how Gateway Checker’s EPCIS and VRS Conformance Testing Platforms can give you and your supply chain partners the confidence that upcoming requirements are met.

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