Will Generic Drug Manufacturing Move Back to the U.S.?

CPhl and InformX conducted a comprehensive report which surveyed both international and domestic drug companies about the future of the U.S. pharma market. Seventy percent of the domestic respondents reported they expected generic manufacturing in the U.S. to steadily increase.

The survey spoke to 110 people spread out across the U.S. supply chain; 36 worked for American companies and 74 worked for international companies in the U.S.

Across the spectrum, outlook for the future of U.S. drug manufacturing overall is positive despite concerns voiced by many about stringent regulations enforced by the FDA.

The biggest complaint is FDA approval times. PMLive quotes Luciano Calenti, present at CMO ACIC, who said, “The FDA is suffocating the industry with regulations, changing them but not improving the rate of approval.”

Despite this, however, there seems to be a consensus that the new regulations are “good for business” with 83 percent of respondents from domestic companies indicating that opinion. With more and more concern about regulatory infringements overseas, the more strict and expensive and potentially longer process might still be an advantage.

Still, even with a number of brand-name drugs coming off patent, only 20 percent of domestic drug manufacturers plan to invest in generics this year.

Instead, 75 percent of domestic drug manufacturers plan to invest in active pharmaceutical ingredients (APIs), perhaps in an attempt to control quality in the supply chain at the most basic source.

According to PMLive, international companies are slightly more leery of the FDA, mostly because they have less experience with the regulatory agency. Despite reservations, one in three international companies expressed interest in acquiring a U.S. facility within the next three years. Thirty percent said they would be investing in generics.

As the Patient Protection and Affordable Care Act continues to grow, it seems intuitive that the generic drug market will continue to grow with it, as generic drugs represent one area of potentially cutting costs. The Generic Pharmaceutical Association estimates savings of $239 billion in 2013 alone. Because safety is of equal if not greater concern, PMLive concludes that the demand for U.S.-based generics will increase.