Moves are afoot to streamline the test requirements for approving biological medicines for sale in the US. The FDA says the goals of the reforms are greater flexibility for biological medicinal product manufacturers while protecting consumer safety – they are also a response to President Obama’s call to ensure regulations do not unnecessarily restrict business.
It is a difficult line to walk between, on the one hand, speeding up the introduction of technological advancements for the benefit of the general public, and on the other, ensuring that the science community’s enthusiasm for ‘new technology’ does not put public safety, the environment, or livelihoods at risk.
We are experiencing quantum leaps in terms of bioscience progress. For more than a decade now, researchers have been able to genetically manipulate plants to produce human enzymes. In 2006, the US Department of Agriculture approved a chicken vaccine produced in plant cells and today companies such as Medicago have a variety of research programmes underway to develop and commercialise plant-based vaccines for human use.
But assuaging concerns about plant-derived biologics for human use has not been easy. As with the GM foods controversy, the benefit/risk balance involved is hard to convey to a wider public especially if they are not suffering the drug shortages that some patients have to endure.
In May, the FDA approved the first drug produced in a genetically engineered plant cell. The resulting drug, Elelyso (taliglucerase alfa), soothes the symptoms in patients with Gaucher’s disease, which causes problems ranging from bone infections to anaemia. Elelyso is similar to Genzyme’s Cerezyme, but cheaper to produce because it avoids the high maintenance that animal-cell cultures require.
The market is waiting to see how readily the drug is accepted by the public. Elelyso’s approval may make the regulatory process more straightforward for other companies and open the doors to other plant platforms.
When most national health authorities are struggling to pay for the ever-growing demand for therapeutic agents, such advances may be the only option in future and research into biotherapeutics should be allowed to go on unhindered by those fortunate enough not to need them.