FDA


A Republican Staffer on the Gottlieb Hearing

This week at a Senate hearing Scott Gottlieb defended his nomination to be FDA commisioner.  Last night at happy hour we caught up with a Republican staffer who was willing to be candid in exchange for remaining unnamed.

 

Staffer:  Oh, yeah, the Gottlieb nomination.  Sweet little thing.  The nomination, I mean.  Seems like the hearing was weeks ago with this whole “nuclear” warfare going on in the Senate over Gorsuch.  

Mendelspod:  The Republicans looked pretty pleased with Gottlieb, as did some of the Democrats.

Still Unhappy with FDA’s Plan to Regulate LDTs, Professional Lab Groups Go Direct to the Senate

It's no secret that America's molecular testing laboratories by and large are worried that the FDA's plan to regulate laboratory developed tests, or LDTs, will severely harm patients. Now they have a new proposal which they are taking directly to Capitol Hill.

Roger Klein is the Medical Director of Molecular Oncology at the Cleveland Clinic. He’s also serving as the spokesperson for the Association for Molecular Pathology (AMP) on the controversial topic of regulating LDTs.

Several weeks ago Roger was in Washington arguing before the Senate’s HELP Committee presenting them a newly drafted proposal that he, AMP and other professional groups feel to be a better solution to regulating LDTs. Currently the FDA is on a path to issue their final guidance for LDTs in a way that treats these lab tests as medical devices.

Klein and the professional lab groups are highly concerned that the FDA’s proposed regulation will be too restrictive and will curtail an industry just as it is blooming. Their proposal: to beef up the existing CLIA regulation so that it includes determining a test’s clinical validity. So far, CLIA has been concerned only with the analytical validity of a test.

But wait a minute, haven't we heard these arguments before? Roger explains in today’s interview that his proposal before the Senate is much more complete than what they had in January.

FDA Will Take Time to Digest Comments on LDT Guidance, Says Liz Mansfield

We’re very pleased to have Liz Mansfield of the FDA on the program to finish up our current Special Report on LDTs Series. Liz is part of the team at the FDA working on the new guidance for the regulation of LDTs, and she was at the recent meeting the FDA held to receive community feedback.

Today we get into some of the details of that feedback. Did Liz and the FDA hear any new issues that they had not already considered? What about the BRAF testing that was mentioned in the meeting? Is there a risk that patients will lose access to some important tests?

In a recent interview in this series, Amy Miller of the Personalized Medicine Coalition urged the FDA to push out their timeline for guidance. In this very open and candid interview, Liz responds that there is no set date for final guidance. “We will take the time it requires to go through them [community comments], analyze them, and decide what we need to do in response and finalize the guidance,” she says. "There is no rush to do that."

Podcast sponsored by: This Month in Biotech - Coming January 30th!

Future of Personalized Medicine at Stake, says Amy Miller of PMC about LDT Regulation

Amy Miller is the Executive Vice President for the Personalized Medicine Coalition (PMC) and joins us in our Special Report on LDTs Series. Though the PMC does not have a position on whether the FDA should regulate LDTs, Amy says that the stakes could not be higher.

“We see the future of personalized medicine is at stake. We urge the FDA to get this right the first time so that personalized medicine can continue to improve the quality of care that patients currently have access to,” she says at the outset of today’s interview.

Amy and her organization represent stakeholders from every side of the current debate on LDT regulation. They hear from industry, payers, providers, and labs. Amy is asking the FDA to step back, take time to respond to the recent community feedback conference, and publish supplementals that will provide more clarity to the guidance, such as how risk will be determined. Amy and the PMC would also like to see the FDA “harmonize” their language with that of CLIA, the current system in place for lab regulation.

“I absolutely think the timeline has to be pushed out,” she says. “The community needs another crack at that framework."

'A Good Year' with John LaMattina

Guest:

John LaMattina, Senior Partner, Pure Tech Ventures Bio and Contact Info

Listen (6:27) Comparing drug approvals: 2014 with 1996

Listen (7:10) More rational drug development?

Listen (1:58) Did public image of big pharma improve last year?

Listen (7:00) The Peter Bach argument

Listen (5:16) Who is winning the debate?

John LaMattina, the former president of Pfizer Global Research, is spending his semi-retirement cultivating the brand of public defender of pharma. As a contributor to Forbes, he showcases some of the great stories of drug development and offers counter punches to pharma’s detractors.

His recent column: FDA Approvals 1996 vs. 2014: The Two Most Prolific Years, But Stark Differences provides the context for today’s interview.

After a look at what is now seen as a banner year for drug development, LaMattina comments on highlights from last week’s JP Morgan Healthcare Conference in San Francisco. He's excited not only about all the business deals, but the new science as well.

The interview ends with a discussion about the debate over drug pricing, and who John thinks is winning it.

Current Version of LDT Draft Guidance Means Much Fewer and Lower Quality Tests for Patients, Says Elaine Lyon of ARUP

Guest:

Elaine Lyon, Former President, AMP; Medical Director of Molecular Genetics, ARUP Laboratories Bio and Contact Info

Listen (4:37) What is at stake here?

Listen (6:16) Is your message being heard?

Listen (8:03) Current guidance would shut down two thirds of current tests

Listen (2:33) What would be the best outcome with guidance?

Today we begin a Special Report on LDTs Series. LDTs, or Laboratory Developed Tests, have been used in healthcare for years to aid in diagnosis and treatment of illness. In the age of genomics, the number of these tests has boomed and become ever more complex. It was not until last year that the FDA, who had long been suggesting it, put out the first version of a draft guidance, or terms of regulation for LDTs. Implementation is expected to take about ten years.

Last week the FDA held a community feedback workshop at the NIH and heard from dozens of stakeholders from around the country. Today we’re joined by one of the speakers at the workshop, Elaine Lyon, the Medical Director of Molecular Genetics at ARUP Laboratories. Elaine was the President of AMP or Association of Molecular Pathologists for 2014.

Elaine joined us on the program last year just before the FDA issued the guidance to make the argument that actually what her lab performs are LDPs or Laboratory Developed Processes and not tests. Because they are processes that require a medical professional, this service is more akin to the practice of medicine and therefore not to be regulated by the FDA, she believes.

Nonetheless, guidance has been issued, and it looks like it will go forward. Elaine and other stakeholders around the community have given their input. Will they be heard? What is Elaine’s best hope for an outcome that will work for laboratories across the country and satisfy the FDA?

Stay tuned for interviews with Liz Mansfield of the FDA and the feedback of other stakeholders in this ongoing series.

The FDA on LDT Draft Guidance Notice to Congress

Guests:

Liz Mansfield, Deputy Office Director of Personalized Medicine, OIR, FDA
Bio and Contact Info

Katie Serrano, Deputy Director of the Division of Chemistry and Toxicology, OIR, FDA
Bio and Contact Info

Listen (4:08) What was submitted to Congress?

Listen (5:09) Why is CLIA not enough?

Listen (4:07) Does the FDA have the resources for this?

Listen (5:54) How will risk be determined?

Listen (2:13) How will you approach panels and whole genome tests?

Listen (2:33) Is NIPT on your radar?

Listen (1:32) What about laboratory developed processes or LDPs?

Listen (1:19) What should labs be doing now?

On July 31, the FDA notified Congress that they will be publishing draft guidance for laboratory developed tests or LDTs.

This means the potential regulation of lots and lots more lab tests. Thousands of diagnostics for diseases like cancer or heart disease or a rare disease.

As with most actions of the FDA, this news has its fans and critics. There are those who feel that a hands off policy of the FDA has fostered innovation and better testing. And there are those who say that some of these tests carry such high risk that they should be regulated as a device or a therapeutic. In any case, others argue, the playing field should be level among test providers.

Here to walk us through what is happening and what will happen is Liz Mansfield and Katie Serrano, both from the Office of Invitro Diagnostics and Radiological health at the FDA.

Podcast brought to you by: See your company name here. - Promote your organization by aligning it with today's latest trends.

Can We Do DTC Genomics Right? Misha Angrist, Part II

Guest:

Misha Angrist, Author, Assoc. Professor, Duke Institute for Genomic Sciences

Bio and Contact Info

Listen (7:03) Presidential bioethics commissions do not have a good record

Listen (5:06) Questioning FDA priorities

Listen (4:31) Not the best arguments in FDA letter to 23andMe

Listen (3:26) Can we do DTC genomics right?

Listen (4:49) Thoughts on A Troublesome Inheritance

Listen (4:30) Self censorship

Today we continue with part two of our interview with Duke Assoc. Professor and author, Misha Angrist, mostly centered around the issue of regulating genomic medicine.

Misha questions recent FDA actions, such as the clamp down on 23andMe.

"I'm generally pretty hard on the FDA," he says.

Misha has a "complex view" about the FDA's letter last November to 23andMe. While he thinks 23andMe "dropped the ball" and went too far in interpreting consumers' genomic data, he also thinks the FDA used the wrong arguments in their letter ordering the DTC company to discontinue its health related testing.

He lauds 23andMe's hiring of Jill Hagenkord as CMO, saying that she "gets it."

We finish with Misha's response to Nick Wade's new book, A Troublesome Inheritance: Genes, Race, and Human History.

Editor's Note: Since this interview was recorded, the 23andMe blog put out an update saying that the FDA had accepted their submission for a new 510(k) application.

Podcast brought to you by: See your company name here. - Promote your organization by aligning it with today's latest trends.

Some Glimpses into the Challenges of Data Visualization Panel Event

Big Data might offer tremendous breakthroughs in healthcare and personalized medicine.  But with the new amounts of terabytes and petabytes flooding organizations today, old architectures aren't able to keep up.

Take the genome, for instance.  We know that there is a ton of valuable information in there.  But how does one go about looking at it?  Doctors have very little time as it is, and decision making becomes a burden becuase it takes days to get answers to questions, if at all.  And what about the opportunity to get genomic data to the lay person as 23andMe was doing?  



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