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Welcome to “the Purple Book” – FDA’s “Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations.”
On the nomenclature front, one immediate take-away is that the FDA makes clearly states:
“The lists cross-reference the names of biological products licensed under section 351(a) of the Public Health Service Act (PHS Act) with the names of biosimilar or interchangeable biological products licensed under section 351(k) of the PHS Act by the FDA (see below for an explanation of the sections 351(a) and 351(k) of the PHS Act).”
Per the FDA:
The “Purple Book” lists biological products, including any biosimilar and interchangeable biological products licensed by FDA under the Public Health Service Act (the PHS Act). The lists include the date a biological product was licensed under 351(a) of the PHS Act and whether FDA evaluated the biological product for reference product exclusivity under section 351(k)(7) of the PHS Act. The Purple Book will also enable a user to see whether a biological product licensed under section 351(k) of the PHS Act has been determined by FDA to be biosimilar to or interchangeable with a reference biological product (an already-licensed FDA biological product). Biosimilar and interchangeable biological products licensed under section 351(k) of the PHS Act will be listed under the reference product to which biosimilarity or interchangeability was demonstrated.
Separate lists for those biological products regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) will be updated periodically.
For those of you following the debate on Non-Biologic Complex Drugs (NBCDs) – such as Copaxone – the fact that the agency is drawing a distinction between CBER and CDER is significant. It is distinction with a difference.
IMHO, products such as copaxone should demand "to be purple rather than orange." Clearly, copaxone has much more in common with biologics -- and since the agency is now making a distinction between large molecules approved by CDER and CBER -- it seems logical to "keep like things together." NBCDs aren't small molecules and don't belong in the Orange Book.
Purple, after all, is the color of good judgment.
Background Information: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations
What are these lists?
These lists are designed to help enable a user to see whether a particular biological product has been determined by the Food and Drug Administration (FDA) to be biosimilar to or interchangeable with a reference biological product. The lists cross-reference the names of biological products licensed under section 351(a) of the Public Health Service Act (PHS Act) with the names of biosimilar or interchangeable biological products licensed under section 351(k) of the PHS Act by the FDA (see below for an explanation of the sections 351(a) and 351(k) of the PHS Act). There will be separate lists for those biological products regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).
For products licensed under section 351(a) of the PHS Act, the lists identify the date the biological product was licensed and whether FDA evaluated the biological product for reference product exclusivity under section 351(k)(7) of the PHS Act (see below for an explanation of reference product exclusivity). If FDA has determined that a biological product is protected by a period of reference product exclusivity, the list will identify the date of first licensure and the date that reference product exclusivity (including any attached pediatric exclusivity) will expire. The list will not identify periods of orphan exclusivity and their expiration dates for biological products as those dates are available at the searchable database for .
Biosimilar and interchangeable biological products licensed under section 351(k) of the PHS Act will be listed under the reference product to which biosimilarity or interchangeability was demonstrated.
What is a reference product, biosimilar, and interchangeable product?
Under section 351(i)(4), a “reference product” is the single biological product licensed by FDA under section 351(a) of the PHS Act against which a proposed biological product is evaluated in an application submitted under section 351(k).
Under section 351(i)(2), “biosimilar” or “biosimilarity” means that the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components, and there are no clinically meaningful differences between the biological product and the reference product in terms of safety, purity and potency of the product.
Under 351(k)(4), an “interchangeable” biological product is a product that has been shown to be biosimilar to the reference product, and can be expected to produce the same clinical result as the reference product in any given patient. In addition, to be determined to be an interchangeable biological product, it must be shown that for a biological product that is administered more than once to an individual the risk in terms of safety or diminished efficacy of alternating or switching between use of the biological product and the reference product is not greater than the risk of using the reference product without such alternation or switch.
What is reference product exclusivity?
Section 351(k)(7) of the PHS Act describes reference product exclusivity as the period of time from the date of first licensure of a reference product, the single biological product licensed under section 351(a) of the PHS Act against which a biological product is evaluated in a 351(k) application, during which a 351(k) sponsor is not permitted to submit and FDA is not permitted to license a 351(k) application that references the reference product. Specifically, if the reference product has reference product exclusivity under this section, approval of a 351(k) application may not be made effective until the date that is 12 years after the date of first licensure of the reference product, and a 351(k) application may not be submitted for review to FDA until the date that is 4 years after the date of first licensure. See 351(k)(7). For additional information on how FDA determines the date of first licensure and reference product exclusivity, please see the draft guidance for industry, “.”
What does the reference product exclusivity expiry date indicate?
The reference product exclusivity expiry date indicates (1) the date that is 12 years from the date of first licensure as described in 351(k)(7); plus (2) any pediatric exclusivity granted pursuant to section 505(A) of the FD&C Act, if applicable. The reference product exclusivity expiry date is the date on which a 351(k) application referencing the reference product may be licensed, assuming it is not blocked by orphan exclusivity and otherwise meets the requirements for licensure under 351(k). To determine whether there is unexpired orphan exclusivity for an indication for which the reference product is licensed, please refer to the searchable database for .
For additional information on determining the date of first licensure for purposes of determining reference product exclusivity, please see the draft guidance for industry, “).”
Why is a determination of the date of first licensure not made for every 351(a) biological product licensed and currently marketed?
Although FDA has not made a determination of the date of first licensure for all 351(a) biological products included on the lists, it does not mean that the biological products on the list are not, or were not, eligible for exclusivity. A determination of the date of first licensure and of when any remaining reference product exclusivity will expire for a biological product submitted under section 351(a) of the PHS Act will generally be made for reasons of regulatory necessity and/or at the request of the 351(a) application license holder.
How often will these lists be updated?
As resources permit, these lists will be updated periodically when FDA licenses a biological product under section 351(a) or section 351(k) of the PHS Act and/or makes a determination regarding date of first licensure for a biological product licensed under section 351(a) of the PHS Act.
What should a healthcare practitioner keep in mind while using these lists?
Professional care and judgment should be exercised in using these lists. Evaluations of biosimilarity and interchangeability for biological products are based on scientific and medical evaluations by FDA under section 351(k) of the PHS Act. FDA’s determination that a product is biosimilar to a reference product or interchangeable with a reference product means that FDA has determined that the biological product meets the requirements for such products (see definitions above).
The “Purple Book” is an easy-to-remember nickname for the “Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations.” Using a color for the nickname of the list draws upon FDA’s long-held practice of using “The Orange Book” to refer to “Approved Drug Products with Therapeutic Equivalence Evaluations,” the Agency’s reference listing of all drugs approved under the Federal Food, Drug and Cosmetic Act. Over the years, health care professionals and other stakeholders have come to use the term “Orange Book” in place of this longer, official title. FDA wanted a similarly user-friendly term for a reference listing biologics, biosimilars, and interchangeable products. During a meeting, a staff member said, “how about purple?” Ever since, we’ve called it the “Purple Book.”
In a Huffington Post article, Patrick Krill, director of the Legal Professionals Program in the Hazelden Betty Ford Foundation, in an Huffington Post voices support for the recent lawsuits by California and Chicago against the manufacturers of opioid painkillers, pointing out that the some pharmaceutical companies “used deliberately misleading marketing techniques to cause an explosion in prescriptions for, and sales of, some of the most addictive chemical compounds man has ever engineered.”
At the same time, per law360.com, numerous pharmaceutical companies asked an Illinois federal judge on Friday to throw out the city of Chicago's suit claiming that their allegedly irresponsible marketing of addictive opioid painkillers has caused a costly public health crisis, arguing that the claims are too generalized to move forward.
In multiple motions to dismiss, Purdue, Janssen Pharmaceuticals Inc., Teva Pharmaceutical Industries Ltd., Endo Health Solutions Inc. and Actavis PLC make similar arguments asking U.S. District Judge Elaine E. Bucklo to toss the case. According to the drug companies, the complaint fails to adequately state a claim against individual defendants, some of which the companies say are barely mentioned in the complaint at all.
“The city simply lumps all defendants together as a group, ignoring relevant differences between the drugs they are alleged to have manufactured, the U.S. Food & Drug Administration-approved indications and the warnings the drugs carried, and the dates the drugs were marketed, and providing no specifics about any defendant’s alleged role in the alleged scheme,” the drug companies’ motion states. “The complaint could serve as a textbook example of improper group pleading.”
In addition to arguing the case should be tossed because of a failure to state a claim, the drug companies urged Judge Bucklo to dismiss Chicago’s complaint based on the doctrine of primary jurisdiction, arguing the city’s claims raise complex issues uniquely suited for the FDA and that those issues are currently being considered by the agency.
“In asking this court to decide scientific and policy matters that fall squarely within the province of, and are currently being addressed by, the FDA, the city has jumped the gun by suing before the FDA has resolved those issues,” the defendants’ motion states. “As multiple courts have done, this court should dismiss or stay this action to allow the FDA to first address these matters within the framework it has defined and is currently implementing.”
The case is City of Chicago v. Purdue Pharma LP, et al., case number 1:14-cv-04361, in the U.S. District Court for the Northern District of Illinois, Eastern Division.
Healthcare innovation saves lives, saves money, promotes economic growth, and provides hope for hundreds of millions of people (both patients and care-givers) in the United States and around the world. But innovation isn’t easy.
In 1950, Americans spent about 5 percent of their income on health care. Today the share is about 16 percent. According to Harvard University economist N. Gregory Mankiw, “many pundits take the increasing cost as evidence that the system is too expensive. But increasing expenditures could just as well be a symptom of success.”
And he hits a homerun with a clear, concise, and common sense explanation. “The reason Americans spend more than their grandparents did is not waste, fraud and abuse, but advances in medical technology and growth in incomes. Medical science has consistently found new ways to extend and improve lives. Wonderful as they are, they do not come cheap.”
The issue of access to innovation is crucial – and the topic of a new paper from the Center for Medicine in the Public Interest, “Access to Medical Innovation: Obstacles and Opportunities.”
Consider the recent FDA approval of Merck’s Keytruda, the first of an eagerly awaited new class of cancer drugs that unleashes the body’s immune system to fight tumors.
As Andrew Pollack writes in the New York Times, “Cancer researchers have been almost giddy in the last couple of years about the potential of drugs like Keytruda, which seem to solve a century-old mystery of how cancerous cells manage to evade the body’s immune system.”
There are many roadblocks beyond those of discovery and development. The complicated and conflicting dynamics of politics, perspectives on healthcare economics, of friction between payers, providers, manufacturers, and regulators, the battle for better patient education, and the need for a more forceful and factual debate over the value of innovation all create the need for a more balanced and robust debate.
Shortly before his death, I had the privilege of a private meeting with Nobel laureate Joshua Lederberg. We talked about the state of applied science, the prioritization of development science, biomarkers, and a host of other future-oriented issues. At the end of the meeting he put everything into perspective in a single sentence. He leaned over the table and said, “The real question should be, is innovation feasible?”
Let’s hope so. Innovation equals hope.
CMPI in participating in a national awareness campaign to accelerate the fight against cancer.
Mylifeisworthit.org, our patient-centered project to promote access to innovative medicine was featured today in a USA Today supplement. It can be found at http://futureofcancercare.com
Each year a quarter of million people, many of them children, die from cancer or cancer related complications because of delay and indifference.
Many have as little as a 6 percent chance of living five years and none have more than a 50 percent chance of living that long.
Meanwhile, it takes two years just to put together a clinical trial to study potential treatments for cancer and another 8 years to complete one. In the time it takes to organize a clinical trial over 200000 people with cancer will die. By the time a clinical trial is finished, 2.5 million people, including 200,000 children with cancer will die.
Defenders of the status quo claim we need to go slow to ensure patient safety. But it is evident that millions of people are being protected to death.
In fact, the situation facing people living with many tumor types is just like the challenge people living with HIV faced nearly 40 years ago. Then, as now, people without effective therapies are dying in less time than it takes to test new medicines.
At the height of the movement to speed up access to HIV drugs, people living with HIV forced the Food and Drug Administration to dramatically slash the time required to study potential HIV medicines. These changes were made to allow patient’s maximum hope for cure and the opportunity for some control over our destiny.
Today, researchers and doctors know more about the underlying mechanisms of cancer than they did about HIV. It is now possible to deliver precise therapy to people on the basis of that individual's tumor. There are no 2 different cancers that are the same anywhere. Just like there are no 2 individuals who have the same DNA, that's the same for a tumor.
And while HIV patients used notebooks and faxes to share data, today’s patients have the digital ability to learn, join, share and take part in advocacy and research faster than ever before.
Cancer is the current system of clinical trials. These require any new drug/treatment to successfully complete three phases of trials aimed primarily at assuring the safety of new drugs. The phase 1 trial is frequently completed in a few months, involves only a few patients and a few hundred thousand dollar investment. The phase 2 and 3 trials for any given new treatments however take up to ten years or more and tens of millions of dollars, all to obtain additional safety data on a few hundreds to a thousand or so patients.
Yet, most cancer trials are conducted as if these technological advances did not exist. People are herded into studies that replace a deep understanding of how to match medicines to tumors with randomized trials (including placebos) that assume everyone responds the same way and for the same amount of time. It’s as if we ignored someone’s shoe size and instead told everyone to try on the same to try a size 6 to see if a shoe fits.
There are treatments now in phase 3 trial with years to go before any possibility of approval, but where the early phase I results of ten years ago are still big improvements over the treatments approved by the FDA many years ago known for these cancers. Only those lucky few are can qualify for the phase 2 and phase 3 trials will get this treatment until the treatment receives FDA approval years from now. What is gained by denying such a treatment to patients right now? Today. What justifies the withholding of a possibly life extending treatment to anyone who needs it and is willing to accept any the possibility that it might not help?
Such an approach and such delay is neither scientifically or morally supportable particularly to people living with a tumor types without effective therapies. Indeed, what we seek has been for HIV drugs and can be done under FDA’s existing regulatory authority.
Nearly 500,000 people each year are told they have a form of cancer that will kill them in two years or less because there is no effective treatment. Each year, half of all people who die of cancer. Yet it takes ten years to bring a new cancer therapy to patients. We can save lives faster and give people living with cancer hope that can last a lifetime.
Here's some actions we can take to reduce the time drastically.
• Empower the Food and Drug Administration to approve new drugs after phase 1 for patients whose tumors respond to a specific treatment in those early studies. Such treatments should be granted conditional approval with the requirement that they are then monitored very carefully in real world settings. NCI funding should be increased to support this approach.
• Increase funding for cancer prevention programs, including early detection and identification of genetic mutations that increase cancer risk.
• Accelerate access to and reduce the cost of experimental treatments to patients, especially children, who have run out of treatment options and can’t wait for or excluded from clinical trials. Patients should be able to use any experimental treatment provided that all data (except the patient’s identity) is made freely available to other patients, researchers and the FDA. Companies that make products available under this program could receive accelerated approval for that drug or another drug under FDA review.
• Eliminate health insurance cost-sharing schemes that create barriers to cancer patients’ ability to access potentially life-saving medicines by passing legislation that provides equal access and insurance coverage for ALL anti-cancer regimens and eliminates fail first policies forcing patients to switch from one drug to another.
If you believe it's important to accelerate access to innovative therapies, join us at http://www.mylifeisworthit.org
From the pages of the Detroit News:
Foreign patent abusers undermine U.S. drug industry
The biggest roadblock to American pharmaceutical innovation isn’t science. It’s intellectual property rights.
Drug companies are struggling to finance the research and development of new treatments. And their difficulties are being seriously exacerbated by some of America’s closest trading partners. Foreign officials are repeatedly violating basic intellectual property protections and siphoning away valuable investment capital.
These abuses need to stop. The drug industry is a crucial part of the American economy. We can’t afford for it to cease innovating.
The largest drug companies typically invest over one billion dollars to develop a new medication. The drug development process usually takes 10 to 15 years. And many of these investments don’t pay off. Only about a fifth of the 5,000 compounds that enter pre-clinical testing every year even make it to human trials. And among those only one in five will ever get approved by the FDA.
Pharmaceutical companies are willing to undertake such costly risk because they hope to eventually recoup these investments once the drug is approved by the FDA. Patents provide innovators with a limited period of market exclusivity, in which competitors are barred from creating low-cost knock offs. The resulting sales help offset those massive upfront expenses.
But these patent protections are now under threat by some major U.S. trading partners.
Our neighbor to the north, Canada, has established uniquely burdensome hurdles for pharmaceutical patent-seekers. Usually, a company seeking a foreign patent must simply prove that its product is useful and new. But Canada demands that patent-seekers overcome an additional hurdle, in which they must “soundly predict” with a high level of specificity the underlying product’s ultimate function.
This creates a Catch-22 for pharmaceutical developers.
In order to “soundly predict” the use of a new medicine, they must gather extensive evidence from clinical trials. But by the time this lengthy trial process is completed, the drug is no longer exotic or new — and so it may no longer meet the “novelty” standard.
Canadian courts have embraced this double-bind and overturned the patents for more than 20 innovative medicines in the last decade. And even more drugs might be at risk of losing their patent protections. Canadian regulators are still allowed to revoke patents years after they’ve been awarded.
India, another major American trading ally, has also undermined the intellectual property rights of pharmaceutical companies. Indian courts have revoked or otherwise broken at least 14 drug patents in the last two years.
For example, although Pfizer’s cancer drug Sutent enjoys patent protections in 90 countries, Delhi recently revoked its patent. A judge unilaterally ruled the drug wasn’t sufficiently “inventive.” Regulators have invoked equally suspect grounds for snapping patents in other decisions, including the need to protect domestic manufacturers.
These patent violations undermine long-term drug innovation. By carving into companies’ ability to recoup its R&D investments, they reduce the funds (and the appetite) for new medical exploration. Firms will be less likely to take that huge risk entailed by the creation of breakthrough treatments and the supply of new life-saving drugs will diminish.
Peter J. Pitts, a former Food and Drug Administration associate commissioner, is president of the Center for Medicine in the Public Interest.
Thought provoking lead story in this week’s edition of BioCentury, Back to School Issue: Paying the piper. Here’s the challenge:
Pharma has lost its pricing power in many countries, as evidenced by reimbursement authorities' willingness to delay or outright deny access to drugs whose costs are deemed unacceptable. Now, the availability of a costly drug in the U.S. that could be given to millions of people has sparked the strongest backlash against drug pricing the industry has yet faced - in the last major market where the government has not adopted any form of drug price controls, according to the U.S. Department of Commerce.
Last year, in "Facing Reality," Back to School argued biopharma companies can no longer assume the market will support premium pricing, even for drugs that deliver meaningful and measurable improvements over the standard of care.
This year, BioCentury's 22nd Back to School essay goes on to argue that the last bastion of free pricing is crumbling, and biotech and pharma had better start experimenting with new pricing models based on value for money while they still have the chance.
And here’s the conclusion:
Back to School does not suggest drug pricing and reimbursement can be fixed easily, and certainly not by the drug industry on its own. Finding approaches that will get new and better medicines to patients sooner, that compensate companies for the health benefits their drugs provide and that don't break the bank will come only through vigorous and collaborative experimentation.
Nevertheless, unless it pursues experiments with the explicit goal of creating a win-win for payers and patients as well, the drug industry can expect controls on prices and utilization to be applied with indiscriminate force in markets worldwide.
Biopharma's brightest minds are hard at work discovering and developing breakthrough medicines. It will be a pitiful shame if patients are denied access because the industry's brightest marketing minds are not creative enough to devise models that will enable healthcare systems to pay for these transformations in healthcare.
What industry needs are brave individual first-movers to get to work on new pricing models that will preempt a cost-plus system and preserve incentives for innovation.
Back to School has described three places where drug companies can blaze the trail.
First, they should pioneer value-based approaches that wed drug prices to the patient- and payer-defined value of outcomes, rather than to the volume of drugs consumed or, in the emerging worst case scenario, the costs to develop and produce them.
Second, drug companies should take the lead on making risk-sharing a reality, not just a catch-phrase for discounts and rebates, and make investments in the kinds of enabling systems that can support appropriate use and reimbursement of medicines, as well as inform development of tomorrow's innovative drugs.
Third, drug companies should spearhead the development of payment models that enable health systems to absorb the cost of cures by enabling payment over the period in which benefits accrue, as long as the drugs continue to work.
As has been the case with Back to School's recommendations in years past, these experiments will require robust collaboration with unfamiliar and even hostile partners. Many will fail.
But the reward for taking those risks will be a menu of pricing and reimbursement options that ensure companies are compensated for the value of both incremental and breakthrough innovations, and that drive revenue and profit by extending access to a bigger pool of patients.
The entire article (and it is definitely worth a read) can be found here.
Via Fierce Pharma – and they buried the lead
Authorities from 8 European Union countries, backed by Europol and Eurojust, have arrested a dozen suspects and seized more than €10 million worth of counterfeit drugs, mostly fakes of erectile dysfunction drugs that an organized crime group was selling online. The raid, announced Monday, came after an investigation that lasted nearly two years.
According to Europol, law enforcement folks from Austria, Belgium, Cyprus, France, Hungary, Slovakia, Spain and the United Kingdom conducted simultaneous raids. They were backed up by Europol and Eurojust. In addition to seizing several million pills, which it estimated were worth well in excess of €10 million, the agents seized cash and luxury cars and froze bank accounts that contained €7.5 million.
The investigation originated in Spain, which was able to provide information for probes in Austria, France and the U.K., Europol said in a statement. It said the fakes originated in Asia, home to many of the counterfeit drug operations.
While erectile dysfunction drugs have long been a target of counterfeiters selling online, Europe is also seeing organized crime move into stealing and faking high-priced drugs, like cancer meds. Authorities this spring warned that vials of Roche's cancer med Herceptin that had been stolen in Italy were showing up across the continent with little or none of its active ingredient.
Because some of the organized crime rings behind counterfeits are based in Europe, the FDA has assigned one of its criminal investigation officers to Europol in The Netherlands. The FDA estimates that 40,000 to 60,000 domain names could be tied to illegal online pharmacies at any given time, and that this number is in a constant state of flux.
Not mentioned in the article – but of relevance – is that in 2013 US National Association of Boards of Pharmacy found that only 257 of 10421 online pharmacies are legally legitimate businesses (less than 2.5%). The remainder either have bogus registration credentials or domain names that make them “suspect.”
Looking for a great job? How about Director of Communications for CDER?
Here are the details:
FDA's Center, for Drug Evaluation and Research (CDER) is searching for exceptional candidates for the position of Director of the Office of Communications (OCOMM). The Office currently has over 100 employees. OCOMM is the central hub for communication expertise, in CDER, focused on the development of consistent messaging to inform and educate the multiple audiences. The Office has a variety of responsibilities including the planning, coordination and evaluation of the policies, procedures, programs in the strategic outreach and communication about drug-related requests.
The incumbent serves as Director, Office of Communications (OCOMM) for the Center for Drug Evaluation and Research (CDER). The Director provides leadership and direction for all Center internal/external communications. The Director is responsible for the creation of a climate for cooperative work relations, and support and understanding of the CDER program objectives. Additionally, the Office of Communications Director advises and counsels the Center Director and CDER leadership on external and internal communications relative to the exchange of information and is the liaison external groups.
Applicants should possess an advanced degree in Communications, Marketing, Public Relations, or Public Affairs.
Successful candidates are those that have experience working closely with highly-credentialed people. They must have substantial experience in Communications, Marketing, Public Relations, and/or Public Affairs. Knowledge of pharmaceuticals is a plus. The candidate should be persuasive, influential, and have the ability to ask the right questions.
Location: Silver Spring, Maryland
Salary: GS-15, $124,995-157,100 Salary is commensurate with qualifications and experience. A full Federal benefits package is also available including: leave, health and life insurance, retirement, long term care insurance, and Thrift Savings Plan (401K equivalent).
Much chatter about a pending FR notice announcing an FDA public meeting on pain medications. Good idea or bad idea?
Well, as the Beltway saying goes, where you stand depends on where you sit. On the one hand there’s the side of science and the public health. Is open public debate useful? Absolutely. And timely.
On the other there are those with less than altruistic interests. The tort bar for one and ambitious politicians for another.
What does “success” look like? For the FDA and like-minded public health advocates, success means advancing safer and more safely used pain medications. For learning and accelerating applied science.
For others it means headlines and a hefty payday.
Which story is more media-friendly? If you don't know the answer to that one, do some internet research on the vaccine/autism link and the debate over SSRIs and teen suicidal ideation.
(Hint – science doesn’t win media inches.)
Who will testify at the FDA meeting? Who will serve on the expert panels? Who will the FDA participants be?
It’s good news that the session will not be an advisory committee. No votes are likely to be taken. Nor will it probably be a Part 15 affair where only “listening” is required of the agency.
It’s FDA leading – but the devil is in the details.
Enoy the paper -- and have a great Labor Day.