The FDA is cracking down on a loophold drug companies use to avoid the requirement that they study products in children; a new study finds nearly 6 in 10 Hispanic adults cite a language or cultural barrier that makes it difficult for them to communicate with healthcare providers; a judge has ordered Wisconsin to pay for gender reassignment surgery for 2 Medicaid recipients.
Since the Pediatric Research Equity Act was passed in 2003, drug companies have been skirting the requirement that they study some products in children by designating more drugs as orphan drugs. Bloomberg reported that the FDA will close that loophole by cracking down on what it considers an orphan drug. According to the exemption, an orphan drug didn’t need to be researched in pediatric populations since the drugs treat diseases affecting a small number of people.
A new study from The Associated Press-NORC Center for Public Affairs Research found nearly 6 in 10 Hispanic adults cite a language or cultural barrier that makes it difficult for them to communicate with healthcare providers. Hispanics also noted concerns that these barriers create for people seeking long-term care services. Of those who do face barriers, about half turn to a family member or another healthcare provider, while 1 in 4 look to a translator, public resources, or online sources.
Two transgender Medicaid recipients in Wisconsin will have their surgeries paid for by the state after a federal judge weighed in. The beneficiaries filed the lawsuit over a 1996 state rule that denies coverage for “transsexual” surgeries, The Hill reported. They argued that the state denying their coverage violated the Affordable Care Act and their rights to equal protection. The judge said that the “likelihood of ongoing, irreparable harm” that the 2 beneficiaries could face outweighed “concerns regarding public health or limiting costs.”