Drugs

Trump Wants to Repeal and Replace Hatch-Waxman?

In response to criticism of a Republican bill to replace ObamaCare, president Trump tweeted early 3/7 that he is formulating a plan to lower drug prices through increased competition. “I am working on a new system where there will be competition in the Drug Industry. Pricing for the American people will come way down!” he tweeted.

No further details about Trump’s drug competition plan were released by the White House, and it is unclear how such a plan would affect the highly successful Hatch-Waxman Act. Hatch-Waxman was signed into law in 1984 to stimulate drug competition and to outline the process for pharmaceutical manufacturers to seek approval for generic drugs. It provided patent and exclusivity protections to innovator companies, while providing incentives for companies to file ANDAs.

Currently, generics represent almost 90% of all prescriptions dispensed in the U.S., but only 27% of expenditures on prescription drugs, according to the Association For Accessible Medicines (formerly Generic Pharmaceutical Association). The Pew Charitable Trusts says drug spending in the U.S. rose nearly 9% in 2015, to more than $300 billion per year, adding that drug spending is rising faster than the rest of healthcare spending.

The 3/6-released Republican bill, American Health Care Act, promises to lower costs for patients. “The bill will improve access to care and restore the free market, increasing innovation, competition and choice,” House Energy and Commerce Committee leaders say. “The legislation provides immediate relief from ObamaCare by eliminating the penalties attached to the individual and employer mandates. Washington will no longer force Americans to purchase expensive, inadequate plans they don’t need and cannot afford. Our bill also dismantles the ObamaCare taxes that have hurt patients, job creators and health-care providers. It repeals taxes on prescription drugs, over-the-counter medications, health-insurance premiums and medical devices.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome