Back in the 1980’s when the Orphan Drug Act was created, legislators, government agencies and even industry weren’t expecting that it would create a multi-billion dollar market where companies now fight fiercely for a share in this segment.
It’s also understood that the timing of the Act was very fortuitous as it was closely aligned with the beginning of US’ growing and promising biotechnology capabilities, two movements that allowed the segment to grow exponentially.
Even though the US has the most developed orphan drug legislation globally, there are still gaps in this market that can allow industry, public sector and academia to go even further in expediting orphan drugs for rare diseases patients and allowing the reach of these new products to be expanded globally.
The impact of new policies and future legislative opportunities to the orphan drug market will be one of the main topics discussed at US’ World Orphan Drugs Congress 2013, next April in DC. Scott Gottlieb, former FDA official, Gayatri Rao, Director of the Office of Orphan Products at the FDA, and representatives from industry, payers and patient groups from Europe and other established markets are some of the speakers confirmed for those discussions.