Quotes from Scott Gottlieb

A seductive technology that works like a dream and improves lives will set off a consumer clamor, whether the new tool is an iPhone 4S or an implantable blood-sugar meter.

By law and institutional culture, FDA seeks to apply a single tool to its approach to regulation - the requirement for pre-market approval. The agency is accustomed to compelling innovators to submit evidence to FDA and seek permission for marketing.

Biologics must be grown in living systems - fermented, for example, in large vats of bacteria cells. This makes them hard to replicate. For decades, biologics weren't subject to competition from copycat generic medicines, even once patents and exclusivities had lapsed on originals.

Regulators at the Food and Drug Administration have a tough job.

If drug development becomes the domain of government researchers, it's a sure bet that political lobbying will eventually trump scientific promise and commercial viability when it comes to investment decisions.

Even with all its political bells and whistles, the Obamacare plans increasingly resemble Medicaid in terms of networks and drug lists.

Cell-based and regenerative medicine can restore human functions lost to disease, including returning some sight to the blind.

We need to make sure that access to a curative drug doesn't become a yardstick by which poverty is eventually measured. Doing so requires a shared commitment between innovators and the insurance plans that are harder pressed to offer these advances to the poor.

The pace at which fundamental discoveries of basic science are being uncovered is accelerating, as is the speed at which medical practice is being transformed by these inventions.

The convergence of information technology and biology allows scientists to translate the human genome into digital data that can accelerate diagnoses and cures.

Gene therapies and other treatments that can cure - not just treat - disease are going to be expensive. All of the cost of innovating and reaping an economic return may need to be recouped in a single payment.

In fast moving fields like cancer, where doctors tailor treatments based on evidence that's constantly evolving, two years can be an eternity of waiting to learn about important science. For some patients, that interval can be fatal.

President Obama famously promised that the Affordable Care Act would not only slow the growth in health care costs, but would also reverse these trends, making the average health insurance plan cheaper. That isn't happening.

ObamaCare has accelerated many of the detrimental trends doctors see in their profession, and introduced new ones.

When I was a medical student, a pulmonary professor of mine cajoled me into joining a clinical trial that she was running. The general aim of the tests was to determine whether prolonged periods of short and shallow breathing would cause a person's lungs to go into spasm. It turns out, as I can attest, that they do.

Once an effective drug is approved to treat a deadly condition, introducing a second drug to treat the same disease can be hard. It's tough to recruit patients with a debilitating disease for a clinical trial when a proven medicine is already available.

When some states introduced mandatory smallpox vaccinations during the epidemic of 1898-1903, Americans resisted by the thousands. The ensuing battles produced medical conventions and case law that altered the balance between government authority and medical practice, in favor of federal control.

Policies I advanced as FDA commissioner aimed to get smokers off cigarettes and onto less-harmful forms of nicotine delivery.

Smallpox can be personally devastating. After a 14-day incubation period, patients experience high fevers, headaches, and sometimes severe abdominal pain. A rash resembling chicken pox appears in the mouth and throat, face, and forearms, and spreads to the trunk and legs. As patients recover, scabs break and pitted scars appear.

Americans broadly consent to funding clinical research because they believe in the promise of medical research. But people support scientific work only if they trust that it serves societal interests, respects patient dignity and operates with guardrails.

One of the biggest factors fueling the angst over drug prices in the U.S. is that some older medicines that should be sold cheaply as generics are still priced very high, often owing to a dwindling number of generic competitors and the rising cost of producing these drugs.

America tolerates a heavy toll from the flu on health and productivity. But if Covid becomes a twin risk, the heath-care system will struggle to fight both at once.

The fact is that Medicaid doesn't even serve well the medical needs of people who should be its principal focus - Americans who are poor in large part because their chronic health problems leave them unable to earn a stable income.

It once seemed that the most profound feats stemming from DNA-based science would spring from our ability to read and detect genes, which we call the science of genomics. But the real opportunities lie in our ability to write DNA, to synthesize new gene sequences and insert them into organisms, resulting in brand-new biological functions.