Approved or not Approved? That is a Good Question.

In a move last month that apparently took at least two device manufacturers completely by surprise, one center of the Food and Drug Administration recommended against an intended use of their products, despite the products’ approval and licensure by another FDA center.

PharmaJet's Stratis is used to vaccinate a Cambodian child against measles. Photo courtesy of Heather Potters.

Recent jet injector models, including Bioject’s ZetaJet and Biojector 2000 and PharmaJet’s Stratis, were approved and licensed by the FDA’s Center for Devices and Radiological Health (CDRH) as needle-free alternatives for injecting vaccines and injectable medications. Both companies had been marketing their devices for influenza immunization in the current flu season.

On October 26th, the FDA’s Center for Biologics Evaluation and Research (CBER) issued a notice  advising healthcare professionals that inactivated influenza vaccines should be administered only with a sterile needle and syringe. The reason: “Safety and effectiveness information that would support labeling inactivated influenza vaccines for delivery by jet injector have not been submitted to FDA.” However, CBER said, individuals who have already received a flu vaccine with a jet injector do not need to be revaccinated.

Currently, only the measles-mumps-rubella vaccine is approved and specifically labeled for administration by jet injector.

So what’s the concern with influenza vaccine? “A jet injector subjects the vaccine to a different pressure than it would receive during administration by sterile needle and syringe and as a result the effectiveness and the safety profile of the injected vaccine may be altered,” according to the CBER document.

Evidently this information had not been previously communicated to the manufacturers. “We were provided no notice by FDA of any concerns about Jet Injectors or FDA’s statement. To our knowledge, no other needle-free injection manufacturer received notice or an opportunity to discuss this matter with FDA,” PharmaJet said in a statement.

Bioject’s President and CEO Ralph Makar was similarly taken aback by the FDA notice. “The FDA communication on the use of jet injectors with influenza vaccines was surprising given that Bioject’s Needle-Free Injection Devices…are both FDA 510(k) cleared with indications for use that describe their use in delivery of subcutaneous or intramuscular injections of vaccines and other injectable drugs,” he said in a statement.

In a public comment at the October meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices, PharmaJet Inc’s chairman Heather Potters said, “Last year we scaled up to provide several hundred thousand syringes, and this season we were expecting to sell several million. Now, our domestic sales have virtually stopped, except for [investigational trials].”

The companies are expected to meet with the FDA in early January to work this out. According to Mr. Makar, “We are looking into the matter to better understand the situation and the FDA’s concerns. A number of Bioject’s Needle-Free Injection devices have been on the market for many years and we are committed to resolving this matter with the FDA in a timely manner.”

-Miriam E. Tucker (@MiriamETucker on Twitter)

About these ads

2 Comments

Filed under Allergy and Immunology, Dermatology, Drug And Device Safety, Family Medicine, IMNG, Infectious Diseases, Internal Medicine, Pediatrics, Primary care, Pulmonary Diseases and Sleep Medicine, Uncategorized

2 responses to “Approved or not Approved? That is a Good Question.

  1. Pingback: Vaccines – Ingredients courtesy ‘Informed Choice’ | The GOLDEN RULE

  2. keith

    I had heard that BD (a needle and syringe manufacturer) lobbied the FDA to wipe out the jet injection companies. It would be interesting to see the who exactly it was that brought this about. A sad day in the world when this device could help so many.

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s