Scott Gottlieb, M.D., is a practicing physician and a resident fellow at the American Enterprise Institute. From 2005 to 2007, he served as the FDA deputy commissioner for medical and scientific affairs and before that, from 2003 to 2004, as the FDAs director of medical policy development. He left the FDA to work on the implementation of the new medicare drug benefit as a senior adviser to the administrator of Medicare and Medicaid Services. Gottlieb is an editorial board member of the journal Value Based Cancer Care and the Food and Drug Law Institutes Policy Forum, and he writes a regular column for the Wall Street Journal. He is also a clinical assistant professor at the New York University School of Medicine.
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The FDA has failed for decades to clearly establish enforcement policies related to pharmacy compounders because the agency doesn't want to concede that it was never supposed to have jurisdiction over the legitimate, local practices of pharmacy and medicine.
FDA regulation of the development and manufacture of drugs is a costly endeavor. It adds to the price of drugs. Politicians cannot simultaneously support increased regulation of drugs and then undermine safety goals when the same rules drive out cost competition, leaving only the more expensive versions available.
A recent decision by a federal trial court gave the Food and Drug Administration the latitude that the agency has long sought to regulate our cells as drugs. It could put the brakes on one of the most promising areas of medical research.
The FDA wants to regulate software used to support the decisions made by patients and health-care providers in the same way it regulates the software embedded in medical hardware such as X-ray machines and infusion pumps.
Until government price controls are lifted, the makers of generics will be unable to cover their production costs.
An aortic valve approved in Europe four years ago will soon be approved in the U.S. Meanwhile, thousands who may have benefited from the device have died.
We need to develop better models for doing clinical trials that are specifically geared toward generating comparative data.
Medicine will suffer if Washington controls the flow of scientific information.
Europeans are approving important new drugs more rapidly than we are.
The information infrastructure required for reconciling coverage with his health plan, or providers, has not been constructed; more than 50% on the plans sold on healthcare.gov offer a very limited choice of providers; providers are reluctant to sign contracts with Obamacare plans, and when they do, reimbursement is being reduced.
Some people end up paying more for their insurance than others. It all depends on what services people want coverage for.
Uncle Sam will spend $2.6 trillion on Obamacare over the next 10 years, according to the Congressional Budget Office. Whats remarkable is how few people this will leave better off.
A death spiral happens when only the sickest beneficiaries get into an insurance pool, causing the cost of medical claims to rise, and in turn raising future premiums.
At least a half dozen state exchanges won't offer full online enrollment thanks to unresolved software problems.
The 340B program was meant to help about 90 hospitals buy drugs to treat the poor. Now 1,675 hospitals qualify.
Obamacare is pushing physicians into becoming hospital employees. The results aren't encouraging.
PPACA tries to engineer its own new constructs, while pursuing provisions that could crowd out entrepreneurs from developing their own ideas. We could end up with neither.
Gottlieb explains how a previously obscure government advisory panel now wields tremendous powers to decide which preventive health care services public and private insurance will cover.
Obamacare doesnt call on government tribunals to euthanize seniors, as some fanciful critics claim, but the bill does kill off private-practice medicine.