May 23, 2012 – At an FDA meeting held last week to explore more effective ways of including patient input in regulatory decisions regarding drug, device and biological products, the agency made it plain to patients, caregivers, patient advocates and patient advocacy groups that it wants patient perspectives to be included in the process.
“This initiative, led by Center for Drug Evaluation and Research Director Janet Woodcock, M.D., is the second of two ‘game changer’ proposals that put consumers and marketing at the center of the discussion, and potentially at the center of the drug approval and use processes,”
said Coalition for Healthcare Communication Executive Director John Kamp, who explained that earlier this year, Woodcock began a discussion about the creation of a third class of drugs where initial prescriptions and refills could sometimes be filled without a physician (http://www.cohealthcom.org/2012/04/30/proposed-otc-drug-distribution-would-expand-patient-access/).
“Together, these proposals mean that FDA is fully recognizing the power of the patient and putting patients at the center of health care in America,” Kamp said.
In a notice published before the May 18 Inaugural FDA Patient Network Annual Meeting, the FDA stated that “establishing a means for obtaining input from patients and patient advocate groups will allow FDA to further enhance its benefit-risk assessment in regulatory decisionmaking.”
Further, the agency said that “patients who live with a disease have a direct stake in the outcomes of the review process and are in a unique position to contribute to the weighing of benefit-risk considerations that can occur throughout the medical product development process.”
At the meeting, CDER’s Woodcock noted that in general, regulation is “the result of a societal consensus that limits the actions or speech of certain parties in society.” She added that although science can inform risk-benefit decisions, it “doesn’t tell us if the benefits outweigh the risks. That’s a value judgment.”
The FDA set forth junctures in the drug approval process where it believes that consumer/patient input would be most valuable: (1) the pre-Investigational New Drug (pre-IND) stage and (2) the pre-New Drug Application (pre-NDA) stage. Input during the pre-IND period is important, according to CDER officials, because such input would fill information gaps about treatment benefits for specific conditions. At the pre-NDA stage, patients could provide input regarding the new therapy’s effectiveness and tolerability.
It appears that patient input also would give the agency additional information about which treatments – drugs or other modalities – are available to and working for patients. This information could help the agency enhance its value judgment-making capability.
“Acetaminophen … very rarely causes devastating liver failure, and some people say that even a rare risk is unacceptable,” Woodcock said. She explained that knowing more about a drug’s impact on a population can help the agency with its decisions, citing a multiple sclerosis treatment that helped many patients but potentially could put certain individuals at risk of progressive multifocal leukoencephalopathy. “The MS community rose up to help keep this drug on the market,” she said.
The agency currently is preparing a list of 20 diseases/conditions for which it will gather patient input under the Prescription Drug User Fee Act V. Incorporating patient perspectives into the regulatory review process is a “major task for FDA over the next several years,” according to Woodcock.
“At this juncture, we need to work together,” she said. “The bottom line is to improve the diagnosis of illness and alleviate suffering.”
April 30, 2012 – Comments are due May 7 on an FDA-proposed paradigm that would allow the agency to approve
certain drugs – that would otherwise require a prescription – for over-the-counter (OTC) distribution under “conditions of safe use.”
An FDA statement regarding expansion of the definition of nonprescription drugs says that the agency believes that some doctor visits can be eliminated under the new paradigm to remove cost or time barriers that may deter consumers from receiving appropriate medications.
“We applaud the FDA for jump-starting a public conversation about how to get medicines into the hands of people who need them with adequate directions for safe and effective use,” said Coalition for Healthcare Communication Executive Director John Kamp. “Public and targeted communication will be key to success. The stakes are high because success here means better health for individuals and better public health outcomes.”
According to Janet Woodcock, M.D., director, Center for Drug Evaluation and Research, OTC drugs have had great success in providing consumers with excellent self-care options. “But our concept of self-care is limited to conditions that can be self-diagnosed and self-treated based on the information in the drug facts box, combined with common knowledge. What we are asking is, should there be more flexibility in the concept of nonprescription drugs? Can we broaden the assistance a consumer gets and increase the types of medicines that might be available over-the-counter?”
The new paradigm would ensure safe and appropriate use by applying special conditions to types of nonprescription products. “For example, before getting a medication, you might have to talk with a pharmacist, or need to have a diagnostic test,” the FDA states. “In other cases, you might have to visit a physician to obtain the original prescription, but not to get refills. FDA is also considering whether some drugs could be a prescription drug and a nonprescription drug with conditions of safe use.”
Among many questions cited in a call for comment published in the Feb. 28 Federal Register, the agency has requested input on the feasibility of this initiative, and what types of evidence would be needed to demonstrate that certain drugs could be used safely and effectively in an OTC setting. The agency also has requested input on dual availability of drugs by prescription and OTC and whether diagnostic tests would need to validated for a change in setting, such as in a pharmacy.
The agency lists a number of potential benefits for consumers from this initiative: an increase in the appropriate use of medication, decreases in health costs, greater access to health screening, easier access to needed medications, and better, more consistent treatment of common conditions. Major challenges with the proposed paradigm shift include reworking FDA rules and separating patients from appropriate medical care. Other potential challenges are: liability concerns, disruption of workflow for often overburdened pharmacists, equipment costs, and questions about health insurance reimbursement.
Peter Pitts, president and co-founder of the Center for Medicine in the Public Interest, said on DrugWonks.com that some questions still remain regarding this proposal, such as: “How will this impact patient compliance? How will this affect one condition masking another, more serious one? How will this change the role of the pharmacist?”
“Hopefully stakeholders will share their views on this proposal so the FDA has the information it needs to consider this option,” Kamp said. “Regardless of the outcome here, FDA is to be commended for thinking outside of the box.”
By John Kamp
April 9, 2012 – The only thing really clear about the new guidance on pre-review of the DTC advertising is that advertisers and their marketing agency partners will need to ensure that their FDA submissions include detailed claims substantiation for every ad submitted. Beyond that, the analysis and commentary on the FDA guidance ranges from “not much new here” to near hysteria.
In fact, my first reaction – suggesting new, extended review delays as well as pre-reviews of virtually all TV ads – was likely an over-reaction. Most importantly, industry has been submitting most ads for pre-review under the PhRMA self-regulatory code for several years, making many of the FDA requirements old hat for industry. Indeed, the draft guidance implements requirements of the last PDUFA reauthorization, Food and Drug Administration Amendments Act, largely supported by industry and trade associations.
Regardless, seldom have I seen such a broad divergence of views on the meaning, scope and impact of a draft guidance from FDA marketing officials.
Although a first reading of the draft guidance appeared to affect nearly all DTC TV ads, the FDA recently responded to an article in “The Pink Sheet” DAILY that its pre-dissemination review policy would involve only 25 percent of DTC TV ads. Thomas Abrams, head of the FDA Office of Prescription Drug Promotion, told the publication that the 75 percent of ads excluded from pre-review “consist of TV ads for products that were already advertised on TV and do not fall into any of the categories stipulated in the guidance.”
In spite of that response and in light
of the guidance’s inclusive list of ad categories subject to submission to the FDA, veteran FDA attorney Arnold Friede believes that drug sponsors will find it difficult to identify TV ads that would not require pre-review, especially because of the “catch all” category defined as “any TV ad that is otherwise identified by FDA as subject to the pre-dissemination review provision.”
In a recent article in InsideHealthPolicy.com, Friede stated that the guidance “is in line with FDA’s ‘desire to control prescription drug promotion,’” and that its de facto prior approval for TV ads raises “some pretty serious statutory issues and constitutional issues.” However, in spite of the clarification by FDA on the scope of the draft guidance, regulatory and legal experts still may counsel clients to err on the side of caution and submit nearly every ad.
I suspect the draft guidance will spark some interesting comments. Indeed, the guidance may be challenged under a provision in the FDA statute limiting pre-reviews, or perhaps even more dramatically as a violation of the “prior restraint” limit on speech under the First Amendment.
And then there are the substantiation requirements. The content of the dossier that the agency is requesting sponsors to submit is much more comprehensive than in the past, even though such data is routinely compiled by companies for internal purposes.
Although there is some debate on the details of the new requirement, the draft guidance calls for the substantiation package to include an annotated storyboard of the proposed TV ad to show which references support which claims. However, the agency specifically states that the storyboard alone cannot be evaluated by the FDA to determine whether a TV ad is acceptable.
“The FDA cannot provide final comments on the acceptability of a TV ad without viewing a final recorded version in its entirety. FDA understands that some sponsors may wish to receive comments from the Agency before producing a final recorded version of the ad,” the draft guidance states. “In such situations, sponsors can submit a pre-dissemination review package without a final recorded version of the ad, but once the final recorded version is produced, it will need to be submitted to the Agency for pre-dissemination review.”
This could create a very difficult choice. Either submit story boards and risk that FDA will fault the final version, or produce the ads ahead of the pre-review and risk repeating the time and expense of the production.
For most companies, the process for having ads vetted by the FDA will include the following steps, according to Bruce Grant, Senior Vice President, Strategy, DigitasHealth:
(1) Submit pre-production concepts for advisory comments
(2) Produce the spot incorporating FDA comments
(3) Submit the finished spot plus the “substantiation package” for pre-dissemination review
(4) Wait 45 days, during which hopefully you will receive any additional comments back from FDA
(5) Re-submit the spot to FDA with Form 2253 and traffic to air.
This process adds another layer to the TV production workflow, but “incorporating FDA advisory comments from pre-production review should substantially mitigate – though not eliminate – the risk of unexpected comments coming out of the 45-day pre-dissemination review,” Grant said.
A potential and perhaps likely glitch is that the FDA draft guidance does not list a time frame in which the agency would provide pre-production advisory comments.
Bottom line, industry should review the draft guidance very carefully and send its comments on the areas it perceives to need revision as soon as possible. The FDA really needs to understand the impact of this document on both the advertisers and the patients they are trying to reach with valuable information about new treatments for their health conditions. The deadline for comments is May 14. Agencies and publishers wishing to assist in formulating the Coalition’s comments should immediately contact Jack Angel at email@example.com.
Feb. 7, 2012 – Responding to patient and professional calls for more industry participation in the Internet and social media, a broad-based industry group – including the Coalition for Healthcare Communication – yesterday issued “guiding principles” at a members meeting in New York City to advance the digital presence of the medicines industry.
The Digital Health Coalition (DHC), co-chaired by Joe Farris and Mark Bard, introduced seven “Guiding Principles and Best Practices for Companies and Users” which represent a consensus of nearly 60 members, including drug and device companies, advertising and other marketing agencies, patient groups and others.
“Industry is leading the way with these principles and we hope FDA soon will follow with more definitive regulatory guidance,” said Coalition Executive Director John Kamp, who is a 2011 Digital Health Scholar. “But patients and healthcare professionals expect robust participation in these media today. Hats off to Joe and Mark for organizing the effort and providing the spark to move us all forward.”
At the same meeting, Bard announced plans to create a task force of DHC leaders to create rigorous guidelines on when companies have control of digital content and thus can be held responsible for it by the FDA and other regulators. “Until the parameters of control and responsibility are more clearly developed, we cannot expect all companies to fully participate in the digital environment,” explained Kamp. “This is the next critical step for the DHC and all stakeholders in digital medicine.”
The seven principles announced yesterday are as follows:
- Regulated healthcare companies should endeavor to participate in social media as a means to promote public health, improve patient outcomes and facilitate productive patient/physician relationships.
- Regulated healthcare companies are not responsible for user-generated content online that they do not control. Regulated healthcare companies are deemed to “control” health and medical content if (i) it owns such health and medical content and has material editorial authority or (ii) it paid for the creation of such content and has material editorial authority over such content.
- Regulated healthcare companies have a responsibility to report adverse events they become aware of. Regulated healthcare companies should follow the existing adverse event reporting rules in place at the FDA.
- Employees of regulated healthcare companies should disclose their material company relationship when posting comments/content or engaging in an online conversation relating to a company product or relevant healthcare issue.
- Regulated healthcare companies should endeavor to respond to questions on sites they control within a reasonable period of time, and to implement reasonable measures to enable timely responses to crisis and emergency situations.
- Regulated healthcare companies should endeavor to make reasonable efforts to correct misinformation that is factually incorrect.
- Regulated healthcare companies should endeavor to appoint employee(s) tasked with the role of “patient liaison” focused on representing the best interests of the patient online.
The DHC is a nonprofit organization with 501(c)(3) status and was created to serve as the collective public voice and national public forum for the discussion of the current and future issues relevant to digital and electronic marketing of healthcare products and services.
Dec. 22, 2011 – As industry groups focus on the details of last week’s proposals from HHS to implement the Sunshine Act provisions of the Affordable Care Act, veteran journalist Cole Werble in PrevisionPolicy recently made a set of predictions on how Sunshine may change the marketing spend of the medicines industry.
Among several predictions, Werble states that “the added burdens and specific rules of the disclosure provisions will continue to nudge pharma budgets away from the broad dispersal of speaking and research funds for practitioners and towards other forms of spending.”
The article highlights key provisions in the proposed regulations that will have an impact on pharma marketing and calls out pitfalls in the proposal.
Meanwhile, the Coalition for Healthcare Communication and other industry groups are sharing information and coordinating efforts to provide robust comments to HHS on many of the details in the Notice of Proposed Rulemaking published Dec. 19 in the Federal Register.
“While HHS wisely decided to postpone implementation, there are several devilish details in the proposed rules,” explains Coalition Executive Director John Kamp. “For example, the proposed rules inappropriately expand the scope of the statute, sweeping in activities not intended by Congress. In particular, many indirect payments to doctors for REMS and certified CME should not be included.”
Many of the relevant details in the proposal are outlined in the Medical Policy Blog published by Thomas Sullivan of Rockpointe Communication: http://www.policymed.com.
For more information on the proposed rule and to join the industry discussion on how to effectively participate in the HHS rulemaking process, contact John Kamp at firstname.lastname@example.org. Comments must be sent to the Centers for Medicare & Medicaid Services by Feb. 17, 2012.
By John Kamp, Coalition for Healthcare Communication Executive Director
Sept. 13, 2011 — Debates over health care and related marketing costs are certain to arise as the Congress and White House struggle to reduce the deficit, stimulate the economy and prepare for the upcoming elections. Meanwhile, the IMS Supreme Court decision is causing a stir in industry and in the courts.
Here are four things you need to know:
1. The IMS Supreme Court decision already is shaking up pending court cases involving FDA and HHS-IG enforcement of medical marketing regulations. As you know, the IMS decision undermines FDA’s ability to ban truthful information by drug companies on off-label uses of drugs. Industry and First Amendment lawyers are closely watching the federal Second Circuit Court of Appeals, a court immediately under the Supreme Court. The IMS case has become central to the appeal of Alfred Caronia, a drug representative being charged by the United States with the crime of including off-label information in sales presentations. In a decision expected soon, the appellate court could agree with Caronia’s lawyers that uttering truthful off-label information cannot be made a crime. Several parties filed special comments based on the IMS decision (see Caronia Amicus Brief). One of the most important of these came from the Medical Information Working Group (MIWG), a coalition of seven medical product manufacturers who recently filed the attached Citizen Petition with FDA asking for clearer off-label regulations. Together, the Supreme Court decision, the MIWG Citizen Petition, and the upcoming U.S. v. Caronia decision could lead to dramatic changes in medical marketing regulation and enforcement. I will be moderating a panel on these developments at the Sept. 23 FDLI meeting (see FDLI Marketing Conference Agenda). The panel includes Harvey Ashman, General Counsel of IMS, Diane Bieri, General Counsel of PhRMA, and Bert Rein of the Wiley Rein law firm, who served as lead counsel in the Washington Legal Foundation case.
2. The deficit super committee is gearing up and quickly must come up with significant budget cuts or tax increases. While industry fared relatively well in last year’s Affordable Care Act, new money must be found and no income source will be overlooked. Indeed, the Advertising Coalition members were not surprised recently when a group targeted the medicines industry even before the committee’s first meeting. The recommendation came from the Pharmaceutical Care Management Association (PCMA), representing PBMs. PCMA sent the attached letter directly to the leaders of the deficit super committee with several suggestions for saving money by suppressing the use of branded drugs, including elimination of the tax deduction for DTC advertising. The Ad Coalition is working with industry groups, including PhRMA and media associations, to address this and other possible proposals.
3. Congressional action on health care marketing issues most likely will arise as part of PDUFA V, the appropriations bill that must pass by October 2012 to enable funding of the FDA. The FDA draft of that legislation has been in the works for more than a year and is about to be sent to Congress. The current draft includes several modifications to FDA approval processes, including new fees for devices and generics, but no proposals for additional marketing rules. Knowing this, a coalition of consumer groups made a last-minute plea to HHS Secretary Kathleen Sebelius to include more marketing restrictions. We don’t expect HHS to agree, but know that the consumer groups will press for these changes on Capitol Hill this year and next. You will be hearing much more about PDUFA V before the bill becomes law.
4. As we wait for Sunshine provisions of the Affordable Care Act to be announced by HHS this month (http://www.cohealthcom.org/2011/03/28/coalition-stakeholders-weigh-in-during-cms-%e2%80%9csunshine-act%e2%80%9d-call/), we not only are seeing the media future in the age of transparency but are getting much better prepared to handle the media spotlight. Last week, ProPublica and local media outlets filed their second wave of stories publishing data on individual doctors who have received payments for working with us and our medical clients. Although many local news outlets picked up the ProPublica material, reporters often contacted the industry and doctor groups, which worked aggressively to provide background and additional context to the stories. The industry owes special thanks for this to both PhRMA and the Association of Clinical Researchers and Educators (ACRE) (http://www.cohealthcom.org/2011/09/08/propublica-reporters-urged-to-provide-context-and-meaning-to-payment-disclosures/).
And, as always, stay tuned.
Sept. 8, 2011 – As ProPublica and its media partners roll out their reports today on industry payments to physicians, doctor and industry groups are urging reporters to include significant contextual information on the nature of these relationships, and note that they provide significant value to both professionals and patients.
Reporters are urged to contact representatives from the Coalition for Healthcare Communication (CHC), the Association for Clinical Researchers and Educators (ACRE), and the Pharmaceutical Research and Manufacturers of America (PhRMA)
Below is a link to the Association of Clinical Researchers and Educators (ACRE) press release. There are several ACRE physicians listed in the press release who are interested in speaking with the media .
Here is a copy of PhRMA’s press release with links to additional resources.
Reporters can contact John Kamp this week in the NYC office (212-850-0708) and on his Blackberry (703-801-4582; email@example.com).
John Kamp, Executive Director Coalition for Healthcare Communication, 405 Lexington Ave, 18th Floor New York, New York 10174; Jkamp@cohealthcom.org ; NY: 212 850 0708; M: 703 801 4582; www.cohealthcom.org; Twitter: RxVoice
PhRMA Statement on Interactions with Healthcare Professionals
Washington, D.C. (September 6, 2011) — Pharmaceutical Research and Manufacturers of America (PhRMA) Executive Vice President and General Counsel Diane Bieri today issued the following statement on interactions with healthcare professionals:
“Interactions between biopharmaceutical research companies and healthcare professionals play a critical role in improving patient care and fostering appropriate use of medicines, and peer education programs – in which expert physicians meet with their fellow healthcare providers on behalf of biopharmaceutical research companies – represent one important element in these interactions.
[Check out the 'Company Interactions with Healthcare Professionals Contribute To Patient Care' page.]
“Through these programs, physician speakers are able to help their peers stay up-to-date with clinical data about new FDA-approved medicines, new uses of medicines, emerging risks and side effects, and more.
“This latest information is essential for physicians, who have to juggle the demands of clinical practice with the need to stay current. That’s why they value representatives of biopharmaceutical companies, who can provide important data during one of the few free moments of a physician’s busy day: lunch. Though a physician’s schedule is often full of back-to-back appointments with patients, they and their staff find this time to learn the information they need to provide the best care.
“It is true that some critics suggest that interactions between companies and physicians are inappropriate, but they disregard the important steps that companies take to ensure the quality of these informational relationships. Biopharmaceutical research companies comply with internal policies, FDA regulations, and the PhRMA Code on Interactions with Healthcare Professionals in order to ensure that their relationships with physicians are ethical and informative.
“We also support transparency in these relationships, including the Physician Payment Sunshine provisions of the Affordable Care Act. We understand that patients may want to know if their physicians take part in peer speaker programs and other activities, such as research, that are sponsored by biopharmaceutical research companies.
“Unfortunately, when taken out of context, publicly available information about physician interactions with biopharmaceutical companies does not convey the value of these relationships, which advance science and promote high-quality patient care.
“For example, according to a recent survey of physicians by KRC Research, nine out of 10 attendees of peer education programs said they found information they received at the programs to be up-to-date, useful and reliable. And more than half of attendees said they often gain knowledge or skills helpful to their practice.
“Ultimately, physicians make treatment decisions on a case-by-case basis, in the best interest of each patient. The information provided in peer speaker programs is just one tool that they can use in making those decisions. And in fact, according to KRC Research, physicians use a variety of factors in making prescribing decisions, including clinical practice guidelines; a patient’s financial status and insurance coverage, including formularies and prior authorization; information from biopharmaceutical companies; and of course, the patient’s particular situation, including drug interactions and side effects. This is evidenced by the high generic substitution rate in America, where nearly 80 percent of prescriptions are filled with a generic drug.
“As we move toward Sunshine Act implementation, we will continue to see increased transparency. We hope that the information provided is viewed within the context of value for the patient, and we hope that our ongoing experiences with transparency will help to encourage the Centers for Medicare and Medicaid Services to move forward in providing regulations on implementation of this important provision.”
By John Kamp, Executive Director, Coalition for Healthcare Communication
While the headlines cite implausible rates of non-compliance with FDA marketing regulations, a close reading of the recent PLOS One article, “Adherence of Pharmaceutical Advertisements in Medical Journals to FDA Guidelines and Content for Safe Prescribing,” demonstrates:
1. the stated preference (bias) of the authors for their own brand of marketing regulation and
2. the underlying challenge industry, doctors and patients face under the current FDA regulation of drug ads.
Simply put, no one knows for sure what’s compliant until the FDA says so, most often in a FDA warning letter. This serves no one including doctors, patients, FDA and industry. Regardless of the authors regulatory preferences, they are absolutely correct in this conclusion: “The FDA could better protect public health by creating new more objective advertisement guidelines requiring transparent presentation of basic safety and efficacy information.” Everyone loses under the current standards because the rules prevent good communication and subject the industry to unwarrented criticism from the press, politicians and medical professionals and uneven, unpredictable enforcement from FDA. Better regulations would enable better informed patients and doctors, thus better patient care.
The Coalition filed a Citizen Petition in March of 2006 asking the FDA to create clear, objective standards for professional and consumer advertising. It’s time for widespread industry dialogue on how to improve these rules to better serve the public health.
The PLOS article can be found on the PLOS website: http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0023336
The Coalition Citizen Petition:
By Kenneth P. Berkowitz, Esq.
July 21, 2011 — Why does the government fail to apply current regulatory requirements and rules to health plans and academic detailing? For some time now, many in the Coalition and industry have wondered why DDMAC, the OIG, the Department of Justice and various state Attorneys General and consumer fraud units – in their haste to attack industry communications and marketing – have failed to apply the same standards to detailing efforts and communications by health plans and academic detailing organizations. Surely these organizations’ goals and plans to promote particular products raise the very same issues and practices concerning kickbacks and off-label promotion that the government has so eagerly attacked when the industry is involved. One would think that bonuses paid by health plans to physicians to prescribe certain products come under the broad government definition of “kickbacks.”
This scenario raises a number of questions. Wouldn’t it be interesting to see the terms under which academic detailing organizations offer their services to hospitals and universities? Is payment tied in any way to healthcare professional prescribing of “detailed” products? Are bonuses available? How does one determine if academic detailers have met their contractual goals? Whatever happened to transparency when it is not directed to the healthcare industry? And why the silence on the part of DDMAC and other government agencies? DDMAC proclaims its “Bad Ad” program is working to catch supposedly improper industry marketing, but why isn’t it directed at others who violate the rules, promote off label or make unsubstantiated claims? The two articles listed below look at some of these issues. Will the government remain silent?
To link to the RPM Report article, “A Word to the Wise as Managed Care Enters Rx Communications,” click here.
To link to the Washington Legal Foundation article, “A FEDERAL UNSALES FORCE?: ‘Academic Detailing’ on Medical Treatments and the Oversight Imperative,” click here.
Please comment here on this compelling issue.
Pitts: BIO’s Call for Drastic Regulatory Change Is On Point
June 27, 2011 — In a recent blog entry on DrugWonks.com, Peter Pitts commended BIO’s proposals to revamp the U.S. regulatory system for new treatments and therapies. Pitts mentions that BIO’s plans, as reported in BioCentury, include a progressive approval pathway for unmet condition therapies, a fixed term for the Commissioner of Food and Drugs, a redefinition of FDA’s mission and the FDA as an independent agency, separate from the Department of Health & Human Services.
Read more on the DrugWonks.com Web site