Tag: FDA

Blog Posts (41)

September 21, 2016

FDA Approval Brought To You By Popular Demand

by Craig Klugman, Ph.D.

In a surprising move, the Food and Drug Administration approved Exondys, a drug that has not been proven to work, did not have a randomized control trial, and that recommended against  by an independent expert panel.  …

September 13, 2016

FDA Moves On Postponing Post-Antibiotic World

by Craig Klugman, Ph.D.

This month, the Food & Drug Administration (FDA) issued a final ruling that certain 19 chemicals used in making “antibacterial soaps and body washes” should be removed from those products.…

August 29, 2016

Testing Donated Blood for Zika: Politics or Prudence?

by Craig Klugman, Ph.D.

The FDA has announced that within the next 3 months, all donated blood in the United States should be screened for Zika virus.…

April 8, 2016

Ethics & Society Newsfeed: April 8, 2016

Can we trust robots to make moral decisions? Last week, Microsoft inadvertently revealed the difficulty of creating moral robots. Why Bioethics Has a Race Problem Moral imagination in bioethics has largely failed African Americans. The disturbing reason some African American … Continue reading
March 1, 2016

Senator Markey and the Unfortunate Politicization of the F.D.A.

Senator Edward (Ed) John Markey (D.-Mass.) announced on January 24, 2016, that he was exercising one of his prerogatives as a United States Senator and placing a hold on the confirmation vote for Food and Drug Commissioner nominee Robert Califf, MD.  President Obama nominated Dr. Califf on September 15, 2015, to succeed Margaret Hamburg, MD, who left the position last year Interestingly, Dr. Califf won unanimous approval by the Senate Committee on Health, Education, Labor, and Pensions. However, Senator Markey questions Dr. Califf’s fitness to serve not because he lacks credible individual qualifications, but because he is upset with the way the agency deals with prescription opioid medicine approvals, and specifically the manner in which the F.D.A. handled adding a label indication for the narcotic pain killer OxyContin (Purdue Pharma LP) to treat children’s pain.

Moreover, Markey is not alone. At least two other senators agree that Califf is not a good choice for F.D.A. commissioner and also place “holds” on the nomination: Senator Bernie Sanders (Ind.-Vt.) believes that Califf is too close to the pharmaceutical industry and lacks commitment in controlling drug prices; and Senator Lisa Murkowski (R.-Alaska) objects because the F.D.A. approved a genetically modified salmon which is a competitor in the marketplace to “natural” Alaska salmon.  Because of these member “holds,” Dr. Califf’s nomination may never come to the Senate floor for a confirmation vote. And with the Obama Administration in its last year, it may not really matter that much anyway. Dr. Califf is presently serving as Deputy Commissioner for Medical Products and Tobacco; and the F.D.A.'s chief scientist, Stephen Ostroff, MD, is serving as acting head of the agency.  Both Drs. Ostroff and Califf are relatively recent F.D.A. administrative additions and probably will collaborate in effecting Obama policy directives.

Regardless, the question remains: Should senators hold up F.D.A. appointments for what appear to be personal political views? Views that are clearly are important, but grounded more in policy disagreements with agency actions that may not be related to the qualifications of the candidates nominated to manage the agency? Surely there are more civil and direct ways of expressing opinions without attempting to grind government to a halt?


The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.


February 5, 2016

The FDA Should Have No Role in Setting Prices for Off-Patent Pharmaceuticals

An article that appeared in the Journal of the American Medical Association on January 4, 2016, written by Johns Hopkins Institute of the History of Medicine and Bloomberg School of Public Health professors Jeremy A. Green, Gerard Anderson, and Joshua M. Sharfstein recommended that the Food and Drug Administration (FDA) act to improve access to approved generic drugs that are becoming scarce because of a lack of competition. It’s surprising that respected historians and health policy educators believe that the FDA should have any such governmental role. As highly regarded as they are, the authors appear neither to fully understand FDA and drug regulation history or health care delivery competition oversight. The FDA has never had statutory authority to regulate drug prices, period. And, they rightly shouldn’t have.

The FDA exists to protect the public safety, health, and welfare by assuring that drugs marketed in the US are safe and effective. The reasonableness of the prices for these drug products is of no concern to the FDA as a regulatory body. In the general scheme of federal oversight, fair business and trade practices are the responsibility of the Federal Trade Commission (FTC) and the Civil and Criminal Divisions of the Department of Justice. These governmental authorities are responsible for the enforcement of the anti-competition and antitrust laws. The FDA has enough to do already; drug pricing should be left in the regulatory hands that are charged with this duty without involving the FDA. There’s no real value of involving the FDA here, except perhaps to muddle the waters more.

Green, Anderson, and Sharfstein are appropriately outraged by the unbelievably high prices charged for some off-patent drugs.  But for the most part, the decreased availability is a function of market forces. As drugs age – and loose their patent protections – newer drug entities are approved and take their place in medicine’s armamentarium. The example the authors cite of the wide availability of amoxicillin is good example of an off-patent drug that still available because the market has yet to find a safer, more effective, low cost alternative for the millions of patients in the US that need a first line broad spectrum antibiotic. Few off-patent drugs have have the same broad use and hence the same wide availability. There are some but their use and availability is a function of the market, not FDA oversight. The shortages or limited supplies of most drugs result not from reduced competition but from the fact that fewer patients need them.

In those situations, in which unscrupulous marketeers and venture capitalists step in the raise the prices of drugs in short supply – even when there are many patients need and can benefit from them – the circumstances are more similar to price-gougers taking advantage of an unfortunate situation. Some states define this as criminal behavior and the alleged misconduct is prosecuted and guilty parties are punished. This would be true if the product were drugs, or milk or gasoline, whether shortly after a natural disaster or some other similar calamity.

Moreover, the recommendations Green, Anderson, and Sharfstein make regarding the FDA’s role are poorly thought out and inconsistent with current commonly accepted practices: (1) The authors think the FDA should allow more “drug compounding” by pharmacists to meet any shortages. Any “compounding” of the volumes necessary to meet shortages would clearly be “manufacturing” as defined in the Food, Drug and Cosmetic Act (FDCA). “Compounding” is typically undertaken by an individual pharmacist for an individual patient; larger scale production is “manufacturing” and FDA oversight would be mandatory. For many years, the FDA has sought greater oversight of “compounding” over the objection of state pharmacy regulators. They have achieved that goal of sorts with the enactment of the Drug Compounding Quality Act (which was Title I of the Drug Quality and Security Act of 2013). (2) The authors also suggest that the FDA “temporarily permit the importation of drug products reviewed by competent regulatory authorities and approved for sale outside the United States.” It’s generally understood that India already manufactures about 80% of the world’s generic drug supply. Most drugs available in the US are already manufactured in India and China. Drug manufacturers moved to these countries over time for economic reasons, because it’s just too expensive to manufacture drugs in the continental US anymore. Of course the approval process for those products that will be marketed here is still handled by the FDA, but the actual product manufacture is elsewhere. It’s particularly curious that Dr. Sharfstein – as a former Principal Deputy Commissioner within FDA from 2009 to 2011 – should advocate for such FDA roles when it was the FDA that was actively involved in drafting the Drug Supply Chain Security Act (which was Title II of the Drug Quality and Security Act of 2013) to better assure the quality of drugs available in the US regardless of point of manufacture. 

Even more curious, the authors recommend the FDA speed up it’s generic drug regulatory approval process. Again, as Principal Deputy Commissioner for the FDA, it seems that Dr. Sharfstein and other FDA officials could have done that already if there had been political will to do so.

Regardless, the FDA should be left alone to assure the safety and efficacy of drugs, and not be involved with drug pricing.

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.


October 12, 2015

An F.D.A. Commissioner With Ties to the Pharmaceutical Industry? Heaven Forbid?

<p style="font-size: 11.2px; line-height: 19.04px;"><span style="font-size: 11.2px; line-height: 19.04px;">On September 16, 2015, </span><a style="font-size: 11.2px; line-height: 19.04px;" href="http://www.nytimes.com/2015/09/16/health/cardiologist-nominated-to-be-head-of-fda.html">President Obama nominated</a><span style="font-size: 11.2px; line-height: 19.04px;"> the internationally known Duke University cardiologist-researcher </span><a style="font-size: 11.2px; line-height: 19.04px;" href="https://medicine.duke.edu/faculty/robert-m-califf">Robert M. Califf, MD</a><span style="font-size: 11.2px; line-height: 19.04px;">, to be Commissioner of Food and Drugs. He will replace</span><a style="font-size: 11.2px; line-height: 19.04px;" href="http://www.nytimes.com/2015/02/06/health/margaret-hamburg-fda-commissioner-stepping-down.html">Margaret Hamburg, MD</a><span style="font-size: 11.2px; line-height: 19.04px;">, who left the agency last March. Dr. Califf – a registered Democrat but well regarded by Senate Republicans – has served as </span><a style="font-size: 11.2px; line-height: 19.04px;" href="http://www.fda.gov/AboutFDA/CentersOffices/ucm452317.htm">Deputy Commissioner at the F.D.A.</a><span style="font-size: 11.2px; line-height: 19.04px;"> since February. The Senate must confirm the commissioner.</span></p> <p style="font-size: 11.2px; line-height: 19.04px;">Immediately prior to joining the F.D.A., Dr. Califf was professor of medicine and vice chancellor for clinical and translational research at Duke. While at Duke, he founded the Duke Clinical Research Institute and served as director of the Duke Translational Medicine Institute. A highly esteemed expert in cardiovascular medicine, health outcomes research, healthcare quality, and clinical research, Dr. Califf has led many landmark clinical trials and authored or co-authored over 1,200 publications in the peer-reviewed literature. He is one of the American Medicine’s most frequently cited authors in the biomedical sciences. His credentials are unimpeachable. Two of Dr. Califf’s area of interests are improving the design of drug research projects and streamlining the regulatory process to bring innovative drugs to market more quickly.</p> <p><span style="color: #34405b; font-family: Arial, Helvetica, sans-serif; font-size: 12px; line-height: 19.04px;"><strong>The Alden March Bioethics Institute offers a Master of Science in Bioethics, a</strong> </span><strong style="color: #34405b; font-family: Arial, Helvetica, sans-serif; font-size: 12px; line-height: 19.04px;">Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our <a style="color: #000099; text-decoration: underline;" href="http://www.amc.edu/Academic/bioethics/index.cfm">website</a>.</strong></p>
August 28, 2015

Marketing Trumps Science, or How the Pink Pill Does Not Even the Score

<p class="MsoNormal" style="font-size: 11.1999998092651px; line-height: 19.0400009155273px;"><span style="font-size: 11.1999998092651px; line-height: 19.0400009155273px;">This month’s blog is going to be a bit of a rant. I don’t generally consider myself a rant-y person, but some of the commentary surrounding the recent </span><a style="font-size: 11.1999998092651px; line-height: 19.0400009155273px;" href="http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm458734.htm">FDA approval</a><span style="font-size: 11.1999998092651px; line-height: 19.0400009155273px;"> of the sexual desire disorder drug Addyi has proven too much for my delicate constitution.</span></p> <p class="MsoNormal" style="font-size: 11.1999998092651px; line-height: 19.0400009155273px;"><span style="font-size: 11.1999998092651px; line-height: 19.0400009155273px;">First, what I am NOT doing: I am NOT denying the existence of hypoactive sexual desire disorder (HSDD), or that for women who are so afflicted it can cause serious distress or otherwise negative consequences. I am NOT challenging the notion that HSDD is a medical problem that warrants seeking a medical treatment or medical solution. I am NOT arguing against pharmaceuticals in general, or here specifically, as a potentially viable medical treatment for HSDD. I am NOT saying all pharmaceuticals should have absolutely no risks or side effects, or should be required to produce overly substantial benefits for it to be appropriate for them to be FDA-approved and released to the market. I am NOT calling into question the claims that there are very real sex and gender disparities in medicine, human medicalization, and medical treatment. And I am NOT disputing the value of empowering women with greater control over their own bodies and their own healthcare.</span></p> <p><span style="color: #34405b; font-family: Arial, Helvetica, sans-serif; line-height: 19.0400009155273px; font-size: 12px;"><strong>The Alden March Bioethics Institute offers a Master of Science in Bioethics, a</strong> </span><strong style="color: #34405b; font-family: Arial, Helvetica, sans-serif; line-height: 19.0400009155273px; font-size: 12px;">Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our <a style="color: #000099; text-decoration: underline;" href="/Academic/bioethics/index.cfm">website</a>.</strong></p>
June 22, 2015

At Long Last: FDA Changes the Law for Hemochromatosis

by Arthur Caplan, Ph.D.

Summer in the U.S. is known for many things—time at the beach, picnics, baseball, thunderstorms, vacations and ice cream.…

October 6, 2014

Misdirected Anger With the FDA Commissioner’s Rather Perfunctory Role?

<p><span style="line-height: 22.3999996185303px;">The September 24, 2014, issue of </span><em style="line-height: 22.3999996185303px;">USA Today</em><span style="line-height: 22.3999996185303px;"> carried a story titled, “<a href="http://www.usatoday.com/story/news/nation/2014/09/24/addiction-painkillers-fda-margaret-hamburg/16150421/">Anti-Addiction Groups Want FDA Chief to Resign: Activists Say Agencies Policies Have Led to Epidemic of Painkiller Abuse.</a>” </span><span style="line-height: 22.3999996185303px;">The first sentence of the news report says: “Anti-addiction activists are calling for the Food and Drug Administration’s top official to step down, saying the agency's policies have contributed to a national epidemic of prescription painkiller abuse.” ABC News reported the story that same day with the lead, “<a href="http://abcnews.go.com/Health/print?id=25717411">Anti-Addiction Groups Call for New FDA Chief.</a>” </span><span style="line-height: 22.3999996185303px;">In the written ABC News commentary, the hype may be characterized in one inflammatory sentence: “In a letter released Wednesday, more than a dozen groups ask the Obama administration’s top health official to replace FDA Commissioner Dr. Margaret Hamburg, who has led the agency since 2009. The FDA has been under fire from public health advocates, politicians and law enforcement officials since last October, when it approved a powerful new painkiller called <a href="http://www.zogenix.com/content/products/zohydro.htm">Zohydro</a> [ZOHYDRO™ ER (hydrocodone bitartrate) extended release capsules, Zogenics, Inc.)], </span><span style="line-height: 22.3999996185303px;">against the recommendation of its own medical advisers.” Both the print and newscast reports came from an <a href="http://bigstory.ap.org/article/fda-chief-defends-approval-hydrocodone-drug">Associated Press report</a> written by Matthew Perrone about a controversy that has been brewing for sometime. </span><span style="line-height: 22.3999996185303px;">The activists’’ letter to Secretary of Health and Human Services Sylvia Burwell is <a href="http://feduprally.org/wp-content/uploads/2014/09/Burwell-Letter-completed-with-signature-Final.pdf">available online</a> and states their position clearly. </span></p> <p><strong style="line-height: 19.0400009155273px; color: #34405b; font-family: Arial, Helvetica, sans-serif; font-size: 12px;">The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our <a style="text-decoration: underline; color: #000099;" href="/Academic/bioethics/index.cfm">website</a>.</strong></p>

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Published Articles (4)

American Journal of Bioethics: Volume 10 Issue 2 - Feb 2010

A Response to Commentaries on ?Blood Donation, Deferral, and Discrimination?

American Journal of Bioethics: Volume 10 Issue 2 - Feb 2010

Blood Donation, Deferral, and Discrimination: FDA Donor Deferral Policy for Men Who Have Sex With Men

American Journal of Bioethics: Volume 8 Issue 4 - Apr 2008

Marketing Off-Label Uses to Physicians: FDA's Draft (Mis)Guidance

American Journal of Bioethics: Volume 8 Issue 3 - Mar 2008

Marketing Off-Label Uses to Physicians: FDA's Draft (Mis)Guidance

News (6)

May 17, 2012 9:51 am

FDA panel backs at-home HIV test that analyzes mouth swab in 20 minutes (CBS News)

An at-home HIV test that claims to diagnose the disease in 20 minutes from saliva on a mouth swab is a step closer to hitting store shelves, now that an advisory panel of experts recommended the test kit’s approval to the Food and Drug Administration.

May 14, 2012 11:44 am

FDA Issues Warning About Experimental MS Therapy (ABC News)

CCSVI therapy, which has not yet been tested in clinical trials, consists of widening narrowed veins in the chest and neck through the use of balloon angioplasty or stents, both commonly used to treat atherosclerosis, or hardening of the arteries. The intervention is sometimes known as “liberation therapy,” or a “liberation procedure,” the agency said. But the FDA added that so far, it has not approved the use of balloon angioplasty devices or stents to treat CCSVI. It also encouraged clinical trials that could solidify the link between the two conditions, and urged patients to discuss the risks and benefits of CCSVI therapy with their doctors.

May 14, 2012 10:06 am

IOM calls for more thorough safety monitoring of drugs (American Medical News)

To track a medicine’s safety, the FDA should create a comprehensive benefit and risk assessment and management plan that is readily accessible to the public and easy to understand, according to the report, issued May 1. Such a document would give physicians and others greater access to information about drugs on the market than they had in the past, said Eric M. Meslin, PhD, a member of the 12-person IOM committee that wrote the report.

May 1, 2012 5:07 pm

Better Ways Needed to Track Drug Safety: Report (US News)

A management plan to gather, assess and respond to data about all medications’ risks from the time they are approved until they are no longer on the market is needed to improve drug safety in the United States, says an Institute of Medicine report released Tuesday.

April 22, 2012 11:57 am

FDA Proposes Guidelines For Nanomaterials In Food And Cosmetics (Medical News Today)

On Friday, the US Food and Drug Administration (FDA) proposed two new draft guidelines for the evaluation and use of nanomaterials in food and cosmetics. The agency said in a Consumer Update that this is the continuation of a “dialogue” that started in June 2011, when they issued a draft of the first guideline on the subject, one that helps industry decide whether an FDA-regulated product involves the use of nanotechnology, by considering for instance the size and properties of the materials.

March 26, 2012 1:34 pm

FDA Told to Act on Farm Antibiotics (Wall Street Journal)

A federal judge ordered the Food and Drug Administration to restart a process that could limit the use of two types of antibiotics in cattle, pigs and poultry, amid concerns such use leads to antibiotic-resistant infections in humans.