Last week Margaret Hamburg took time out during a health care summit at the Cleveland Clinic in Ohio to talk to me about finding more money for the agency, making it tougher and stronger, and restoring the public's faith in the FDA.

Below are some outtakes from the interview. Margaret Hamburg was named in March by President Obama and confirmed in May as the 21st commissioner (and second woman) to head this agency that oversees $2 trillion of what Americans spend on products.

First, I want to restore faith and trust in the FDA as a science-driven agency. I want to be a vocal advocate for the resources we require. It's stunning how underfunded we are given the importance of what we do. 25% of every dollar spent by Americans is regulated by the FDA.

During a crisis we have to not be afraid to communicate rather than circle the wagons, which has happened before. We have been taking a very clear-eyed look at past problems to learn from those mistakes.

We're undermining our own best interests if we have a very robust investment in biomedical research and a scrawny investment in regulatory science and support for the FDA.

We are starting up a new center for tobacco products, and we've hired on a terrific new director. We will be moving forward on areas of labeling and issues around the marketing of tobacco products, especially marketing to youth.

Check out my complete interview with the new FDA commissioner here.

And then there were four.

Today a fourth major online genetic testing start-up was announced: the San Diego-based Pathway Genomics. Like the Big Three--23andme, deCodeme, and Navigenics--Pathway is hoping that if they build it, the people will come.

So far, it's unclear if they will anytime soon. None of the current companies have released sales figures, suggesting the response so far may not be huge. This is not unusual with an early stage technology, though this has hardly stopped Pathway from throwing their genetic proclivities into the fray.

Many experts remain skeptical that the science of determining genetic risk factors for diseases such as cancer is ready to be applied to individual consumers. But a buzz has been gathering for some time that genomics--and its close-cousins proteomics and envirogenomics--will one day revolutionize medicine, and how we view ourselves.

The Big Four and their investors-- hich have included Google, Genentech, and venture powerhouses such as Kleiner Perkins--are assuming this will happen sooner rather than later. Pathway also has major league financial backing, including investment from the Founders Fund--led by former Paypal co-founders Peter Theil, Ken Howery, and Luke Nosek, and Napster co-founder Sean Parker.

Many of the services Pathway is proffering are available on the other sites. Like the others, the company is offering genetic counseling for customers, though for a small fee. Pathway also plans to offer social networking on its site. "We have investors and founders involved in Facebook and Linked-in, so we think this is important," says CEO and founder James Plante.

Yet the company is different from its competitors in several ways:

· Pathway is cheaper, offering ancestry testing for $199 and health markers for $249. Ordering both packages costs a discounted $348. The next cheapest product is from 23andme, which charges $399 for its FullEdition. 23andme also offers a "research revolution" edition for $99 for people with certain diseases--migraines, psoriasis, epilepsy, and others--who agree to participate in a research study. DeCodeme's main product costs $985; Navigenics has just reduced their price to $999. Each service has differences--check my "You 2.0" series analyzing the three sites on Portfolio.com, and check out the sites themselves for the latest changes.

· Pathway has invested in its own government-approved lab to test their customer's DNA. deCodeme in Iceland has its own lab, too, although Pathway is the only company with three major DNA genotyping hardware systems--from Illumina, Affymetrix, and Sequenom. This provides Pathway customers with more gene markers than its rivals. "We are technologically agnostic," says Pathway Chief Scientific Officer David Becker.

· Having a lab and the technicians and scientific personnel to man it makes Pathway less a software play than some of its rivals - though deCodeMe in Iceland remains the company with the most scientific depth as a decade-old drug and genomics company that has discovered some of the more important genetic markers for disease that are used by all of the other companies.

· Pathway is also offering slightly more results on more traits than even 23andme, which previously held the record. They are planning to provide genetic results for over 90 disease traits and, for the first time, DNA risk factors for several medications that can cause side effects or neutralize a drug's effectiveness.

· The company is asking customers to provide family history information that they say will be integrated into risk factor profiles. "You might have a high risk for a rare genetic disorder, but if you don't have this disease in your family history, this is not a high risk," says Becker. He adds that Pathway will not offer over-all scores for a customer's risk for disease. "We don't think there is enough information in single genetic markers to come up with that kind of score," he says.

The company has not yet revealed all the details of their product--how they will analyze results and will deal with the preliminary nature of some of the information for example. But Becker says they will release more information in the next few weeks.

Pathway has promised to let me test-drive their product. After I get my results, I'll let you know how it works and how it compares to the other main DNA testing sites. Much of the promise of consumer genetics remains in the future, though the arrival of Pathway offers another signal that even if the DNA gold rush isn't quite here yet, it is coming.

In 2005, I wrote a profile of the geneticist Francis Collins that referred to him as an apostle of genetics. Then the director of the Human Genome Research Institute at the National Institutes of Health, Collins was, and is, an evangelical Christian who also believes strongly in evidence-based science and evolution--and in spreading the word about the power of genetics and molecular biology to radically reshape medicine and society.

Whether talking to members of Congress, high-powered scientific leaders from around the world, one of his patients, or students in his lab, Collins's zeal and ambition for pushing his vision of science is palpable and intense--and often delivered with a rural Virginia drawl that puts listeners at ease even as he aggressively pushes his agenda.

He acquired his aw-shucks demeanor--and penchant for wearing flannel shirts and corduroy pants--growing up in the Shenandoah River Valley in Virginia. His parents came from New York City but checked out of urban life to run a back-to-nature farm, and to produce a professional summer Shakespeare theatrical company. Folk singers often showed up when he was a boy, and Bob Dylan spent his 18th birthday in the Collins farmhouse.

A man who loves to speak and to play his guitar--he was recently shown with his ax dressed like Bon Jovi in a GQ spread called "Rock Stars of Science"--Collins learned to be skilled at performing and persuading, he told me, by playing roles in his parents' plays. At the age of seven, he wrote a children's play version of The Wizard of Oz and played a role uncharacteristic for this firebrand of science: the Cowardly Lion.

He first trained as a chemist, then became a physician, discovering God while trying to sort out the mysteries of life and death at age 27 during his residency at the University of North Carolina. He later landed at the University of Michigan, where he drew attention for codiscovering the gene mutations for cystic fibrosis in 1989. In 1993, he received an unexpected invitation from then director of the NIH, Bernadine Healy, to succeed James Watson as the head of the Human Genome Project--which Collins first declined, but later accepted.

Collins has a preference for big ideas, and has continued to organize large-scale projects to map and organize the genomes of humans and other organisms. Lately, he has been pushing a stronger linkage between environmental factors, such as chemical pollutants and stress, that interact with genes, calling for a $400 million increase in the Gene Environment Initiative, which he helped get passed by Congress in 2006.

He is a savvy operator on Capitol Hill, where he succeeded in not only funding billions of dollars in genetics research, but also pushing the passage last year of legislation that protects Americans from being genetically discriminated against by insurers and employers.

We can expect much more in the way of big projects that link different disciplines and institutes at the NIH--and possibly a reorganization of an organization that has many overlapping institutes that have grown up ad hoc over the years.

His emphasis on big might explain why Collins loves big motorcycles, including a red Harley-Davidson that he wheeled out one day a couple of years ago when I visited him at the NIH. Looking a little incongruous with his lean, tall, slightly nerdy look riding high on his hog, he took me on a ride--and proceeded to roar up and down Wisconsin Avenue in Bethesda like a big kid. Like a good scientist, he also meticulously obeyed every traffic rule, signaling turns and shoulder checking when he changed lanes. I'm sure he followed the speed limit, though I couldn't see his speedometer from the backseat.

Collins will be a fierce advocate for personalized medicine. Last year, he left the NIH after 15 years to write a book that he was unable to publish while still working for the government. He has been mum on the details, but in talking to him over the years, I suspect that it will describe the need to move more aggressively with validating genetic markers and other crucial elements of personalized medicine, while calling for a broad plan to move research and applications of medical discoveries toward a more individualized approach based on a person's own genetics and physiology.

The announcement of Collins's nomination has been long expected and was delayed in part because he has been finishing his book--his second endeavor as an author after the 2007 publication of the best-selling The Language of God, which argued in favor of theistic evolution--a process that Collins calls BioLogos. Recently, Collins cofounded the BioLogos Foundation to support the idea of fusing faith and science.

He has strong opinions about how to organize scientific endeavors, leaning toward an open exchange of data and information and less toward commercialization--a point that he has made repeatedly since fending off efforts to privatize the results of the Human Genome Project, which he headed up in the 1990s. Yet he has been careful in recent years to balance the need to promote accuracy and validation of genetic testing with a desire to promote commercial endeavors such as 23andMe and deCodeme--companies that offer the direct-to-consumer genetic testing for dozens of diseases and traits.

Though critical of the accuracy of some of these tests, Collins believes that they will be useful in the long run. Under a Collins directorate, we could see an accelerated effort to standardize and regulate these companies, either voluntarily or, if that fails, through mandatory rules.

Francis Collins has been known to make enemies. He still bristles when the rivalry between him and Craig Venter, his bitter adversary during the race to sequence the human genome in the 1990s, is brought up. Other rivals from his past also remember that the young Collins was willing to aggressively outmaneuver rivals to get ahead.

"I have to be honest about my own personality," Collins said. "I am competitive. I find it particularly exciting as a scientist to get at something that hasn't been done before. It's an incredible downer to get scooped. This is human nature."

When I sent Collins the profile that I wrote, with the allusion to St. Paul--which appears in my 2006 book Masterminds: Genius, DNA and the Quest to Rewrite Life--I was sure that he would be annoyed. But he wasn't. He found it amusing, signing an e-mail soon after as coming from "Francis, aka St. Paul."