Tag Archive FDA

ByOffice of Advocacy

Small Business Losing Patience with New Drug Supply Automation Regulations

By Apollo Fuhriman, Region 10 Advocate

In December, I met with Meishelle Haverkamp who works for a local affiliate of Swisslog Healthcare, a company that provides automation solutions for pharmacies, including those in hospitals.

In her role, she has seen that a possible upcoming guidance regulation could actually increase time and costs within healthcare, especially with hospitals and clinics that have a decreased capacity to absorb these costs (or even to find enough qualified people given geographic constraints).

Congress passed the Drug Supply Chain Security Act in 2013.  The Food and Drug Administration is working on guidance for the implementation and rollout of the act. If guidance includes that every dose of a medication must be tracked every time it is touched within the hospital walls (from the time it is received from the wholesaler until the time it is administered to the patient), this will have an adverse impact on the workflow productivity of hospital pharmacy staff, without providing much value, according to Haverkamp.

“The burden will be excessive for small, independent hospitals,” she added. They can’t afford the radio-frequency identification technology that will most likely be employed by large health systems if the DSCSA guidance requires per dose tracking within the hospital walls.” (An RFID tag can cost more per dose than some of the medications.)

The DSCSA’s purpose is to keep counterfeit medications from entering into the supply chain. How often do counterfeit medications enter the supply chain within a hospital’s walls? Haverkamp could not find even anecdotal evidence to suggest this has ever happened in the United States.

Haverkamp explained the typical process for the majority of medications that are in a hospital:

  1. Once a medication is received from a wholesaler, it is staged for put away.
  2. Then it is restocked in the carousel or on a shelf.
  3. Then it is picked and sent to an Automated Dispensing Cabinet on the nursing floor.
  4. And then it is picked and administered to the patient.

With the exception of the final administration, each of these steps is done in bulk, and common practice is to scan one dose and then key in the total quantity of doses being picked or put away. If the pharmacy technician had to scan every dose, it would take an exceedingly long time and be a highly repetitive process.

Sometimes, well-intentioned regulations can create a greater burden and in some instances, possibly reduce time that medical professionals have to spend with patients.

Apollo Fuhriman is the Office of Advocacy’s regional advocate representing Washington, Idaho, Oregon and Alaska. Our Regional Advocates in the 10 SBA regions stand ready to hear from you about small business concerns and to help you level the playing field for small businesses in your state.



ByOffice of Advocacy

Advocacy Helps Guide Small Food Importers through FDA Regulations

By Yvonne Lee, Region 9 Advocate

Jacklyn Sher’s parents were refugees from Laos who came to the United States in 1976 with nothing but hope for a better life for their family. They worked hard—their first job was as night janitors at a fast food restaurant—and saved enough money to buy an old station wagon. The Shers then started delivering soy sauce to southern California food businesses. Twenty-seven years later, HC Foods is a successful food import and distribution company serving food businesses throughout the western U.S. This family-owned business now employs 25 workers and the Shers are most proud that they can provide for their employees health insurance, 401(k) and other benefits.

Recently Jacklyn was one of over 100 food importers, distributors and business owners who participated in an SBA National Ombudsman Regulatory Fairness Hearing in Cupertino, California, that the Office of Advocacy helped convene. It was the first time that most of these business owners have attended a government meeting and spoken before a government body about their experience with federal regulatory compliance and enforcement. For the past two years, Advocacy’s Assistant Chief Counsel Linwood Rayford and regional advocates have worked with food businesses like HC Foods to make sure they were aware of, and engaged with, the regulatory reviews under the U.S. Food and Drug Administration’s (FDA) Food Safety Modernization Act (FSMA). This law was enacted in 2012 to ensure all food available to American consumers—domestic and imported—adheres to high safety standards.

Food importers told Advocacy that they support the goals of FSMA since their businesses depend on food safety as it directly affects their bottom line. However, they said that any new regulations must take into account the differences between independent small operations like theirs and large businesses. Food importers said they are particularly interested in FSMA’s Foreign Supplier Verification Program (FSVP). The proposed FSVP regulations would require importers to verify that the importer’s foreign suppliers produce food in compliance with processes and procedures, including risk-based preventive controls, that provide the same level of public health protection as those required under the domestic requirements of the Food, Drug and Cosmetic Act.

Small importers assert that the new program’s verification requirement would create an undue economic burden on small firms since they wouldn’t have the needed human and financial resources that larger corporations have to meet compliance. While these businesses told Advocacy they welcome their role in ensuring food safety, they said that the regulations need to be flexible, practical and reasonable to reflect the small food businesses’ resource challenges. Moreover, as more regulations under FSMA are implemented, they suggest that the final rules need to be enforced fairly and with transparency.

Advocacy has facilitated several public forums where small business stakeholders dialoged with FDA officials over the FSMA’s foreign facility re-inspection, importer re-inspection fee rates, importer risks and food transport safety provisions. The Asian Food Importers Alliance told Advocacy the discussions were positive and it would be the first time they would submit a comment letter to a federal agency.

As the FSMA’s regulations progress, Advocacy will continue to work with food importers and other industry stakeholders to ensure they have the opportunity to add their voice throughout the process.