Atlanta, U.S.A. — From June 28th Supreme Court ruling that upholds the Affordable Care Act (ACA) to the FDA’s approval of the first new obesity drug in 13 years, June has been a hot month for major news impacting the U.S. biotechnology sector.
Biopharmaceutical drugmakers have held their collective breath wondering what would happen with health care reform and many hesitated to commit resources to implement certain provisions, such as those related to the Physician Payments Sunshine Act, which requires them to report payments made to physicians and teaching hospitals. With this ruling, it’s now clear they need to act. The ACA also protects a 12-year marketing exclusivity provision for biologics and upholds a regulatory pathway for biosimilars, which is positive news for biopharmas.
“Bottom line, despite the myriad complexities which biotechs must now weed through, the ACA translates into important business opportunities for biopharmas, not the least of which is a burgeoning biosimilars sub-industry,” said Lynn Yoffee, executive editor of BioWorld Today. “Despite over-hanging world economic conditions, biotech is one U.S. business sector that is working. The sector grew by 6.4 percent between 2001-2010 compared to a 2.9 percent decline in overall U.S. private-sector jobs. Twenty two new biotech drugs have been approved already in 2012, the latest including promising new drugs for breast cancer and obesity. President Obama is poised to sign critical legislation which creates new user fees for generics and biosimilars. And capping off June, the Supreme Court upheld the ACA, yielding both positive and negative ripples.”
BioWorld has kept industry insiders abreast of these key stories as they happen, sometimes within minutes. “And we go beyond the breaking news; we provide key perspective on the impact for the drug development sector,” Yoffee said.