News Feature | February 25, 2014

New Pilot Launched For Pharmaceutical Companies Who Have Proven Themselves

Source: Bioprocess Online

By Liisa Vexler

As part of a pilot program, it was announced that the Food and Drug Administration (FDA) would loosen regulations on 13 key pharmaceutical companies who have the rights to import in the United States. These respected companies are to receive special allowances so that it frees up the time of the FDA to investigate and track other companies. Focus will now be directed to those who are importing unapproved drugs or are crossing the border illegally. Expectedly, because the 13 companies which will receive less scrutiny have earned it, better attention can be given where it really needs to be.

By complying with the rules of the pilot program, the special companies will be allowed expedited entry of the five drugs that they import most regularly. They will still be subject to regulation, but the scrutiny with which other companies have to undergo will be lessened. The high powered equipment that was once allocated for checking on the companies which have proven themselves will now be redirected to looking for more high risk activity in other areas.

Increased expedited entry translates into profits for those who are chosen to participate, resulting in a slew of companies applying for such a coveted position. The pilot program is soon to run with utmost caution and rights will be revoked if there are any signs of abuse or lax in import quality. The success or failure of the new regulation will be watched closely in the months to come.

Source: http://thehill.com/blogs/regwatch/healthcare/198641-fda-loosens-pharmaceutical-regs