Regulatory Focus™ > News Articles > GSK Announces Grant Program to Support 'Electroceuticals,' Raising Regulatory Questions

GSK Announces Grant Program to Support 'Electroceuticals,' Raising Regulatory Questions

Posted 11 April 2013 | By

Could "electroceuticals" be the newest healthcare product category worth watching? UK life sciences manufacturer GlaxoSmithKline thinks it is, and is putting up money to what it deems is quite literally "the million-dollar question":  What promises might this new field of medicine hold?

What Are Electroceuticals?

In relative terms, a million-dollar bet isn't much considering the almost $40 billion in revenue GSK made in 2012, but it is a step in the right direction, the company said in a statement.

That's because bioelectronics medicine, which refers to the combination of nano-scale medical devices contained within a capsule or other medication, could one day revolutionize the medical field.

At present, it is envisioned that a electroceutical could trigger nerve fibers to restore vitality to organs or other functions. GSK observed in a statement that, "The functions and organ systems of our body are, to a significant extent, controlled by electrical signals that travel along the nerves."

Bioelectronic medicines would, in theory, treat diseases by controlling those electrical signals, manipulating how the body communicates with itself.

A New Vision

"One day, such 'electroceuticals' could potentially coax insulin from cells to treat diabetes, regulate food intake to treat obesity, and correct balances in smooth muscle tone to treat hypertension and pulmonary diseases," GSK speculated in a press statement. "We believe this is a vision now worth pursuing. And it is why we are seeking to grow and integrate a research network that will become a new bioelectronics community."

"We are confident that this field will deliver real medicines, and we are mobilizing resources for this journey," the company's researchers wrote in an accompanying editorial in the journal Nature.

Potential Regulatory Challenges

But even if the company is successful in generating new therapies with its grant program, which will see 20 research grants given to teams to conduct basic research, the new products could face significant regulatory hurdles.

Regulators, for example, have been slow to issue guidance or regulations pertaining to nanotechnology, which represent unique challenges at various stages of the review cycle. For example, nanoparticles can be especially difficult to manufacture because of quality control issues. And regulators have at times expressed skepticism about the safety of the particles, postulating that they could be associated with unique health risks if they are absorbed or inhaled into the body improperly.

Japanese and EU regulators recently announced that they would start work on a new nanotechnology guideline aimed at providing a stable approval pathway for products built on the technology, but wide utilization may still be challenging even if sponsors are aware of the regulatory challenges.

But that's also just one aspect of the regulatory paradigm that would face electroceuticals. Because the products would have a primary mode of action that is based on electricity, and not a chemical or biological action, they would also likely face reviews from device regulators.

Depending on how the medicine is composed, it might also include a pharmaceutical or biological active ingredient, making it a combination product, further complicating matters.

So while the first million-dollar question might be whether the concept works at all, the second million-or far more, according to PhRMA-might well be spent figuring out regulatory questions.

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