Seriously, What is Going On at the Office of Combination Products?

 I’ve been hearing one question over and over in conversations over the past few weeks: “What is the Office of Combination Products (OCP) really doing?” So I started asking experts—and everyone seems to have a different answer. 

 

OCP associate director John Barlow Weiner is surprised at the question. “OCP was set up because industry wanted it—its creation was proposed by the device industry.”

 

OCP’s mission, Weiner says, is simple and has not changed. The office uses an algorithm to determine which center should be primarily responsible for a product’s market pathway. It then coordinates with the various stakeholders to ensure that products are reviewed appropriately.

 

At its inception, OCP was hailed as a facilitator, aimed at helping industry members navigate the confusing FDA pathways to bring combination products to market quickly and safely. But four years later, the perception of the office may be less favorable. Some have said, sympathetically, that OCP is in a tough spot, trying to accomplish goals without independent authority. Others have offered harsher criticism, saying the office has overstepped its bounds. Finally, some analysts believe the OCP is moving products more often to CDER than to other centers.

 

In addressing the question of OCP’s authority, Weiner says an important role of the office is engagement. “We are here to conduct and coordinate outreach and enhance communication,” he says. He notes a recent workshop regarding the final rule on current good manufacturing (CGMP) processes for combination products. The workshop was intended to clarify CGMP duties for combination products and codify a streamlined mechanism for manufacturers. “What we want industry to know is that the rule doesn’t change or expand their existing duties,” Weiner says. Further, he adds that OCP welcomes feedback on the draft guidance, which it intends to publish as soon as possible this year.

 

Another key criticism relates to the classification of a product by OCP, which is currently the topic of litigation. The situation raises questions about the agency’s standards for classifying some products. “OCP ignored its own precedent,” John Smith, a partner at law firm Hogan Lovells, said during a roundtable media discussion. 

 

Here’s the backstory: In September, district court judge Rosemary Collyer issued a decision regarding OCP’s categorization of Prevor’s Diphoterine skin wash as a combo product. The product is a spray can containing a chemical, but the company says the chemical only accounts for about 20% of the product’s ability to wash skin in an emergency situation. Prevor says pressurized washing accounts for 80% of the therapeutic effect, rendering the product more suited to a device pathway. The court said FDA failed to provide a reasoned basis for its classification decision. The lay implication is that OCP must recategorize the product as a device. 

 

Because the case is ongoing, Weiner can’t say much. However, “we are in the process of responding to the court’s decision,” he says.  

 

The last observation is that overall, OCP seems to be pushing more to the drug center. David Fox, a partner at Hogan Lovells, expressed this idea during the same media roundtable mentioned earlier. “We see CDER exercising more leadership and control,” he noted. As Smith pointed out, such a trend is worrisome, because the regulatory pathway for drugs is more difficult and expensive than for 510(k)s. Weiner believes that more combo products continue to be regulated by CDRH than by CDER. He agrees that higher user fees at CDER than at CDRH can pose a substantial challenge to some product developers.

 

Industry might be feeling the unwanted consequences of increased coordination among the centers. Wiener notes that the agency has made efforts to ensure reviewers work together and apply consistent standards when assessing products. 

 

“Our feedback from industry is that OCP is helpful to them,” Weiner says, adding that companies generally say they have a positive experience. “OCP is here to effectively and thoughtfully work with industry.”

 

Weiner will be continuing outreach efforts at BIOMED Boston with guidance on submitting products to various review centers. The conference will be held April 10-11 in Boston. 

 

Heather Thompson

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