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January 8, 2014

Dietary Supplements Under Closer Scrutiny

dietary supplements.jpgIn mid to late December 2013, FDA appeared to be taking a closer look at dietary supplement claims and products, particularly those with health claims or potentially dangerous ingredients. Three recent actions/notifications that took place within days of each other worth note include actions against Risingsun Health (bloodroot-containing products with claims to treat cancer), Star Scientific, Inc. (anatabine-containing products with claims to treat traumatic brain injury ("TBI") and other ailments), and Blunt Force Nutrition (synthetic anabolic steroid with claims for muscle growth).

On December 19, 2013, FDA posted a News Release that on December 4, 2013, Risingsun Health, a Livingston, Montana dietary supplement maker was found in civil contempt of violating the terms of a consent decree of permanent injunction that had resolved a case brought by FDA against the company and its owner in February 2010. The consent decree had barred the company from developing and selling topical bloodroot and graviola products, new drugs, new animal drugs, and dietary supplements. The 2010 case concerned the company's advertisements on various websites and sales of unapproved drugs that claimed to treat cancer, and the decree was entered in November 2010. In February 2013, the U.S. sought an order of civil contempt, because Toby McAdam, owner of Risingsun Health, and his company continued to manufacture and distribute products, including products containing bloodroot, which violated the decree, after FDA sent several letters concerning the alleged violative conduct. Federal judge Sam E. Haddon, District of Montana, held a hearing on the government's contempt motion on October 21, 2013. The Court found McAdam in contempt, requiring him to cease selling dietary supplements and new drugs and to pay both $80,000 in liquidated damages and $4,936.48 in attorneys' fees. Regarding the finding, Melinda K. Plasier, Associate Commissioner for Regulatory Affairs, stated, "The court's ruling will ensure that this business cannot harm consumers physically or economically by selling unapproved and deceptive dietary supplements."

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December 4, 2013

23andMe Suspends Access to Health-Related Information

23andme.jpg23andMe, the Google-backed direct-to-consumer genetic testing provider, has suspended its health-related genetic testing in response to FDA's November 22, 2013 Warning Letter. In the Warning Letter, FDA directed 23andMe to "immediately discontinue marketing [its Saliva Collection Kit and Personal Genome Service, "PGS"] until such time as it receives FDA marketing authorization for the device." While 23andMe will discontinue access to health-related services, 23andMe will continue to provide access to raw genomic data as well as ancestry-related applications. Also, customers who purchased 23andMe prior to FDA's Warning Letter will still have access to health-related results.

The Warning Letter deemed the PGS a medical device under Section 201(h) of the Federal Food, Drug, and Cosmetic Act ("FD&C Act"). 21 U.S.C. 321(h). Section 201(h) defines a medical device as "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article" that is "intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease" or is "intended to affect the structure or any function of the body." FDA determined that the PGS fell within this definition, because it was marketed as providing, "health reports on 254 diseases and conditions." In particular, 23andMe was marketed as a "first step in prevention" for diseases like diabetes, coronary heart disease, and breast cancer.

FDA is particularly concerned about the "potential health consequences that could result from false positive or false negative assessments for high-risk indications." For example, a false positive BRCA-related risk assessment [A BRCA mutation is a mutation in either of the genes BRCA1 and BRCA2. Harmful mutations in these genes produce a hereditary breast-ovarian cancer syndrome in affected families.] Mutations in BRCA1 and BRCA2 are uncommon, and breast cancer is relatively common, so these mutations consequently account for only five to ten percent of all breast cancer cases in women.[may lead to unnecessary prophylactic surgery or chemoprevention. On the other hand, a false negative may lead to a failure to appreciate actual risk. FDA was also concerned about drug response assessments, such as warfarin sensitivity or clopidogrel response. For example, a false positive BRCA-related risk assessment [a BRCA mutation is a mutation in either of the genes BRCA1 and BRCA2 that is associated with a hereditary breast-ovarian cancer syndrome in affected families] may lead to unnecessary prophylactic surgery or chemoprevention.

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August 19, 2013

Global Supply Chain Highlighted in FDA Public Meeting Discussing FDASIA's Title VII

globalmap.pngEarlier this month, FDA released the transcript of its July 12, 2013 Public Meeting on Implementation of Drug Supply Chain Provisions of Title VII of the Food and Drug Administration Safety and Innovation Act ("FDASIA"). The day-long public meeting concerned the drug supply chain provisions and was meant to discuss how the Agency means to implement those provisions, and for FDA to hear public comment about those provisions that specifically address imported drugs and importers.

The morning session opened with Margaret A. Hamburg, M.D., Commissioner of Food and Drugs, who spoke on "The Challenges of Globalization." Hamburg praised the passage of FDASIA and recognized FDA's expanded authorities under the legislation. In a theme that was repeated throughout the morning session, Hamburg stressed that the drug supply was becoming "progressively more complex and more global" and that while FDA's mission and focus remain domestic, the reality is that the agency rapidly becoming a global agency. In fact, nearly 40% of all U.S. drugs are made elsewhere, 80% of the sites that manufacture active pharmaceutical ingredients ("APIs") are located outside the U.S, and imports are now coming in from over 150 countries. This global expansion has forced FDA to increase its collaboration with its international regulatory counterparts. The Commissioner highlighted the higher penalties for counterfeit drugs, the proposed rule for the administrative detention of drugs, and the draft guidance on penalties for manufacturers that refuse, delay, limit, or deny FDA inspections as key new developments that should help FDA secure the safety and integrity of the supply chain.

John M Taylor III, Counselor to the Commissioner and Acting Deputy Commissioner for Global Regulatory Operations and Policy, spoke next on "FDA's Globalization Strategy." Echoing the comments of the Commissioner, Taylor noted the increase in U.S. imports that has "eliminated the distinction between domestic and imported products" and recognized the trouble FDA has had keeping up with a more complex drug supply chain that involves more ingredients and more players. Threats to that supply chain include: (1) adulteration of products, (2) counterfeit products, and (3) cargo theft. In particular, Taylor noted how FDA was not prepared--both technologically and statutorily--for the alarming rise in Internet pharmacies and drug products being shipped through the mail and air courier systems.

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July 17, 2013

Facility Inspection Guidance Issued by FDA: Delaying, Denying, Limiting, or Refusing a Drug Inspection

magnifying glass.jpgOn July 12, 2013 FDA issued new Guidance for Industry: Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection. The Guidance document illustrates circumstances where the FDA will treat the occurrence as contrary to section 501(j). These are divided into four sections: (1) Delay of Inspection, (2) Denial of Inspection, (3) Limiting of Inspection, and (4) Refusal to Permit Entry.


FDA, under the jurisdiction of the Federal Food, Drug & Cosmetic Act ("FD&C Act") Section 704(a), has the authority to carry out inspections of facilities by duly appointed FDA employees. These inspections are to be undertaken at reasonable times, within reasonable limits and in a reasonable manner.

FDA has not always been able to carry out its tasks. Consequently, in light of the recent Food and Drug Administration Safety and Innovation Act ("FDASIA"), which was signed into law in July 2012, and in particular Section 707 of FDASIA, which added 501(j) to the FD&C Act, the FDA now deems as adulterated a drug that "has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection". (emphasis added)

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April 25, 2013

FDLI's Annual Meeting Features FDA Seeking More Resources and Regulatory Authority and More (Part 1 of 2)

Thumbnail image for FDLILogo.jpgOn April 23 and 24, 2013, the Food and Drug Law Institute ("FDLI") held its Annual Conference in Washington, D.C. As expected, FDLI's Conference featured the FDA Commissioner, Margaret A. Hamburg, M.D., presentations from leaders from all of FDA's Centers and the Chief Counsel, Elizabeth Dickinson, and leaders from industry, academia, and the legal bar. Unlike previous years, however, there were far fewer FDA attendees due to budget cuts, and FDA seemed more reluctant to use the Conference as a platform for announcing new policy or initiatives.

Hamburg kicked off the Conference with her recognition that FDA's budget was cut, along with other government agencies, noting that it would make times tight but that there are no planned furloughs. Hamburg said that this fiscal year, FDA lost about $209 million-$126 million in budget authority and $83 million in user fees. FDA will continue to collect user fees, but FDA cannot use them this fiscal year due to the sequesteration issue. Hamburg said that the reduced budget would mean reductions in programs but did not specify which ones. Yet, at the same time, Hamburg emphasized that FDA has been busy implementing its new regulatory authorities, including the new Center for Tobacco Products and authorities in the Food and Drug Administration Safety and Innovation Act ("FDASIA").

Hamburg stressed that it has become more and more apparent that its regulated industries need to build quality in their products. She highlighted that quality issues have caused two out of three drug shortages, and FDA has uncovered "shockingly unsafe drugs" at compounding pharmacies. Over the past several months, Hamburg explained, FDA has been inspecting compounding pharmacies and has found unidentified black particles in what were supposed to be sterile injectable products, rust and mold in sterile rooms, and products being processed with bare hands. At the same time, FDA has encountered increased resistance during its inspections, resulting in at least two cases needing administrative warrants. Hamburg said that FDA believes there should be a distinction between traditional and nontraditional compounding--traditional is individualized to patient; nontraditional is sterile product prepared out of state compounded and anticipated without a prescription. For nontraditional compounding, FDA has asked Congress for more clear FDA authority to monitor and examine records in the "patchwork" of compounding rules.

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October 24, 2012

Compounding Pharmacies Under Increased FDA Scrutiny

pharmacy.jpgThe Centers for Disease Control and Prevention ("CDC") has reported 21 deaths caused by and 271 cases of fungal meningitis linked to compounded painkiller steroid injections as of October 19, 2012. The New England Compounding Center ("New England Compounding") located in Massachusetts shipped more than 17,000 vials containing contaminated steroid injections of preservative-free methylprednisolone acetate to 23 states resulting in approximately 14,000 patients receiving injections. Based on ongoing reports, it appears that New England Compounding was acting more like an unregulated drug company than a pharmacy preparing a drug product specifically for a single patient based on that doctor's prescription. "The red flag that they had overstepped was that they were producing 17,000 units of this steroid," said Marcus Ferrone, Associate Professor of Clinical Pharmacy at the University of California, San Francisco, who also directs the Drug Products Service Laboratory that compounds various drug products and has its own pharmacy course for students.

The current meningitis outbreak has led to a renewed scrutiny of the regulations for compounding pharmacies, pharmacies that specialize in taking existing drugs and formulating them, such as New England Compounding. Doctors and clinics often rely on compounding pharmacies to supply medications instead of major pharmaceutical companies, because often the drugs from compounding pharmacies are cheaper and in greater abundance. Much of the regulation of compounding pharmacies is performed not by FDA, but by state boards with varying standards.

FDA, wary of the potential danger of unregulated compounding pharmacies, developed guidelines for them culminating in the enactment of Section 503A of the Food and Drug Administration Modernization Act of 1997 ("FDAMA"). Section 503A exempted compounded drugs from the regulations instated by the Federal Food, Drug, and Cosmetic Act of 1938 (FD&C Act) for new drugs provided that they conform to a number of regulations, including that the compounded drug provider refrain from advertising the compounding of a specific drug. The U.S. Supreme Court found this to be a restriction on advertising and that Section 503A violated the First Amendment's free speech guarantee. Thompson v. Western State Medical Center, 535 U.S. 357, 360 (2002). Since the rest of Section 503A was found not be severable from the restriction on advertising by the court below and this finding was not challenged at the Supreme Court, the Supreme Court's decision invalidated the entire statute designed to regulate compounded drugs and compounding pharmacies. Id.

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October 22, 2012

Avon Wrinkle Care Receives Warning Letter from FDA

antiaging.jpgOn October 5, FDA sent a warning letter to Avon Products, Inc. ("Avon") concerning the cosmetic company's online promotion of its anti-aging skin care products. The letter, which FDA posted last week, objects to Avon's marketing claims for a variety of its anti-wrinkle products. Specifically, it warns that they "appear to be intended for uses that cause these products to be drugs under section 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act ['FD&C Act']."

The cited statutory provision (21 U.S.C. § 321(g)(1).) defines "drug" to include "articles (other than food) intended to affect the structure or any function of the body of man or other animals." FDA asserts that Avon's marketing claims indicate that the creams and serums listed in the letter are intended to affect the structure of human skin tissue, in which case they would fall under that definition. For example, the company's website describes that the Anew Clinical Advanced Wrinkle Corrector as "formulated to boost shock-absorbing proteins to help strengthen skin's support layers," and "start rebuilding collagen in just 48 hours." While it is not out of the ordinary for anti-wrinkle products to claim to reduce the appearance of wrinkles and fine lines, FDA believes that Avon's statements go too far. According to the letter, the products are "not generally recognized among qualified experts as safe and effective for the above referenced uses" and are thus new drugs, requiring marketing approval.

Written by Rachael P. McClure

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Congress has prohibited the introduction of new drugs into interstate commerce without filing, and subsequent approval of, a new drug application ("NDA") as stated in 21 U.S.C. § 355(a). A new drug application ("NDA") must include, among other things, "full reports of investigations which have been made to show whether or not such drug is safe for use and whether such drug is effective in use." Id. at § 355(b)(1). Other requirements address labeling information and manufacturing controls. Id. The warning letter asks Avon to review its website and product labels and requests a response within 15 days of receipt (October 20) detailing the steps the company has taken to correct the alleged violations. At least some of the accused descriptions still seem to remain on Avon's website.

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September 7, 2012

Makena Compounding Case Dismissed - FDA's Enforcement Discretion Not Subject to Judicial Review

Thumbnail image for vaccine.jpgOn September 6, District of Columbia District Judge Amy Berman Jackson granted FDA's motion to dismiss claims brought by K-V Pharmaceutical Company ("K-V") either because the claims were unreviewable as discretionary FDA enforcement activities or failed to state a claim. Jackson's Memorandum Opinion helps solidify FDA's position that its discretion not to take an enforcement action is presumed to be immune from review unless Congress has otherwise provided "meaningful standards . .. for defining the limits of that discretion." (citing Heckler v. Chaney),

Makena™ is essentially a story about K-V's bid to take advantage of provisions under the Orphan Drug Act to obtain seven years of exclusivity to market the active ingredient in Makena™ (17-hydroxyprogesterone caproate) for women who have had a singleton pregnancy and a history of prior preterm delivery. Under the Orphan Drug Act, no other company can obtain approval to market the same active ingredient for this indication, which affects less than 200,000 patients per year in the United States, until this exclusivity would have expired. Prior to approval of Makena™, however, pharmacies had been compounding the same active ingredient for individual patients based on individual prescriptions--not a marketed product--at far less cost, around $10-20 per injection rather than the initial price of Makena™ at $1500 per injection, or up to $30,000 for the entire treatment. For more background, see, for example, an earlier blog here.

K-V had hoped that orphan drug approval would block competitors for seven years and its approval would make FDA take additional enforcement actions against pharmacies that had been routinely compounding the same active ingredient for the same indication. Indeed, many had feared, including a number of Congressmen, that FDA would take such actions, causing the cost of treatment to dramatically rise, under a general assumption that an approved drug product would be preferred, from a public health perspective, over a compounded product.

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July 25, 2012

FLH Partner Malkin Adds Biosimilars to ACI's Clinical Trials Conference in Boston

Thumbnail image for 3699948229_d7732f8df0_o.jpgOn July 17, 2012, FLH Partner Brian J. Malkin joined other experts in the field of clinical trials to discuss methods for ensuring safe and compliant domestic and international clinical trials. New to the ACI's Clinical Trials Conference running for more than seven years was Malkin's presentation "Safely Conducting Biosimilars Clinical Trials: Understanding FDA's Requirements for Biosimilar Clinical Trials". The audience was comprised of many individuals seasoned in traditional clinical trials, who came to the conference in Boston to learn about the newest trends in clinical trials.

Some of the featured government speakers included Karena Cooper, J.S., M.S.W., Acting Associate Director of Policy and Communications and Regulatory Counsel, Office of Scientific Investigations ("OSI"), Center for Drug Evaluation and Research, FDA, and Mary E. Crawley, Assistant U.S. Attorney, Eastern District of Pennsylvania. Other featured speakers included former government enforcers and top in-house counsel from sponsor biopharmaceutical and medical device companies, contract research organizations ("CROs"), hospitals, universities, and research institutions.

Cooper described FDA's new inspection platform, where FDA does not need to inspect a facility to issue a warning letter, and the reorganization of the Office of Compliance. In terms of postmarket studies, sponsors are now provided with milestone timetables where failure to complete a milestone by a certain time will result in a violation. While a sponsor may show "good cause" for failure to meet a milestone, FDA has a very limited high bar, essentially for items completely outside the sponsor's control. Examples where FDA did not find good cause included difficult recruitment, costly studies, or development of data in lieu of the data that the sponsor agreed to provide. Regarding postmarket studies, however, FDA has already issued its first warning letter dated February 17, 2012 that utilized the no-inspection format. In this letter, FDA provided the sponsor with 30 calendar days to respond. FDA's Office of Compliance also has new civil money penalties to enforce its provisions that Cooper said FDA is "actively considering" but has not utilized yet. Cooper also described how FDA is working with the European Medicines Agency ("EMA") for joint and observed inspections, where there is a "robust" confidentiality agreement in place.

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July 17, 2012

FDA E-Mail Whistle-Blower Investigation Continues as New Documents Are Revealed

whistle.bmpIn February 2012, FDA Lawyers Blog wrote regarding FDA's secret e-mail monitoring of whistle-blowers in the Center for Devices and Radiological Health ("CDRH"). Now it appears that FDA's surveillance program, which began as an effort to determine whether five FDA scientists were leaking trade secret information, may have been much broader than previously known. According to a New York Times article published on July 15, an FDA contractor inadvertently posted a database containing more than 80,000 surveillance-related documents onto a public website. These documents revealed the extent of the surveillance program that tracked communications between the scientists and Congressional officials, journalists, and others. The surveillance software utilized by FDA allegedly tracked keystrokes, intercepted personal e-mails, and took screen shots of letters being drafted to members of Congress, the Office of the President, and the Office of Special Counsel ("OSC"), an independent federal agency which investigates whistle-blower retaliation claims.

Federal agencies have broad power to monitor employees' computer usage. In fact, FDA computers warn employees when logging on that they have "no reasonable expectation of privacy," and that the Agency may intercept data for any lawful government purposes. However, it is still possible that FDA acted unlawfully when intercepting certain legally protected communications, such as, attorney-client communications, whistle-blower complaints, and workplace grievance filings. The OSC sent a memorandum to all government agencies in June identifying the legal restrictions and guidelines that agencies should consider with regard to monitoring employee communications. Members of Congress have demanded an investigation into the legality of the FDA's program.

Written by Douglas Oosterhouse

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FDA defended the program, saying it restricted surveillance to the five scientists suspected of leaking trade secret information. The Agency established the operation after the Inspector General at the Department of Health and Human Services refused to launch a criminal investigation into the scientists' alleged wrongdoing. FDA officials acknowledge that the operation intercepted communications that the scientists had with Congressional officials, journalists, and others, but FDA maintained that the e-mails "were collected without regard to the identity of the individuals with whom the user may have been corresponding." Additionally, FDA claimed that they did not intend to prevent employees from making these communications, and that individuals outside of the agency were not targets of the operation.

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July 5, 2012

European Pharmacovigilance Goes Into Effect July 2

eyemouthnew.jpgOn July 2, the much heralded new European Pharmacovigilance legislation came into operation. This new piece of legislation is aimed at promoting and protecting public health by strengthening the existing Europe-wide system for monitoring the safety and benefit-risk balance of medicines and provides regulators with a range of new or improved tools to ensure that patients are not exposed to unnecessary risks when taking medicines.

Highlights of the new legislation include:

  • The establishment of a new scientific committee, the Pharmacovigilance Risk Assessment Committee ("PRAC").

  • A clarification of the roles and responsibilities leading to more robust and rapid European Union ("EU") decision-making.

  • The engagement of patients and healthcare professionals in the regulatory process.

  • An improved collection of key information on medicines, e.g., through risk-proportionate, mandatory post-authorization safety and efficacy studies.

  • More transparency and better communication.

The first meeting of the new key committee, PRAC, will be on July 19 and 20, 2012. PRAC's mandate includes, among other things, "All aspects of the risk management of the use of medicinal products including the detection, assessment, minimization and communication relating to the risk of adverse reactions, having due regard to the therapeutic effect of the medicinal product, the design and evaluation of post-authorization safety studies and pharmacovigilance audit".

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June 25, 2012

Online Pharmacy Founder Arrested for Allegedly Selling Counterfeit Drugs

imagesCAJSKD4S.jpgThe founder of an online pharmacy was recently arrested for allegedly selling counterfeit prescription drugs. Specifically, the United States government has charged Andrew Strempler ("Strempler"), the founder of Mediplan Health Consulting, Inc.--also known as ("RxNorth")--with one count of conspiracy to commit mail fraud and wire fraud, as well as two counts of mail fraud. A grand jury returned an indictment against Strempler for these offenses in June 2011, but because Strempler was deemed a flight risk, the indictment was sealed until his arrest.

In support of the charges, the indictment alleges that Strempler falsely claimed that RxNorth was selling safe prescription drugs that complied with the rules of United States regulatory authorities. These claims were allegedly made through RxNorth's website and brochures. The indictment alleges that contrary to these representations, Strempler and his co-conspirators obtained the prescription drugs from various countries without ensuring the drugs' safety or authenticity. More specifically, Strempler is alleged to have operated a facility in the Bahamas, where the drugs were shipped. The orders were then allegedly filled in the Bahamas, and given labels stating that they had been filled by RxNorth in Canada. Further, the drugs allegedly were not sold in accordance with FDA regulations, because they were allegedly counterfeit, misbranded, and not FDA-approved. Additionally, the indictment alleges that RxNorth falsely boasted that it was using the "best equipped" laboratory to test its drugs for safety and authenticity even though RxNorth actually only had one piece of equipment that was capable of limited testing.

The indictment further claims that the FDA previously wrote a letter to Strempler in 2001, warning him that it would be illegal to sell drugs that were not approved by the FDA. This allegation, if proven true, will likely be used to show that Strempler knowingly violated federal law. If convicted of the charges, Strempler faces up to twenty years in prison. Additionally, the government seeks forfeiture of the proceeds that Strempler obtained from his allegedly unlawful conduct. The government estimates that Strempler's proceeds have been at least $95 million. This criminal case underscores the federal government's commitment to ensuring that only genuine, FDA-approved prescription drugs are sold in the United States.

May 31, 2012

Canadian Drug Importation Amendment Rejected by Senate

canada.jpgIn a recent 43-54 vote, the U.S. Senate defeated a proposed amendment to the FDA Safety and Innovation Act (S.3187), which we previously reported on here, that would have allowed Americans to purchase drugs from Canadian pharmacies. The Amendment, proposed by Sen. John McCain (R-Ariz.) sought to lower the cost of prescription drugs for Americans.

In the days leading up to the vote, McCain had been critical of the pharmaceutical industry for lobbying the Senate to defeat the Amendment. "In a normal world, this would probably require a voice vote, but what we're about to see is the incredible influence of the special interests, particularly pharma, here in Washington, that keeps people who cannot--that have to make a choice between eating and medicine," McCain said. "So what you're about to see is the reason for the cynicism that people have for the way we do things in Washington. Pharma, one of the most powerful lobbies in Washington, will exert its influence again at the expense of average, low income Americans who, again, will have to choose between medication and eating."

While the Amendment was defeated, several fellow Republicans voiced support for McCain's proposal. Sen. Charles Grassley (R-Iowa), a proponent of importation of Canadian pharmaceuticals, reasoned that allowing importation would provide economic incentives. "I have always considered drug importation a free-trade issue," Grassley said. "Imports create competition and keep domestic industry more responsive to consumers. If Americans could legally and safely access prescription drugs outside the United States, then drug companies will be forced to re-evaluate their pricing strategies."

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May 9, 2012

Clinical Investigator Disqualifications Extended to All FDA-Regulated Products

3699948229_d7732f8df0_o.jpgOn April 30, FDA published in the Federal Register final regulations amending the scope of its clinical investigator disqualifications. Now when the Commissioner determines that a clinical investigator is ineligible to receive one kind of test article (drug, device, animal drug), the clinical investigator is also ineligible to conduct any clinical investigation that supports an application for research or marketing for other FDA-regulated products, including foods and tobacco products. FDA amended its regulations "to protect the rights and safety of subjects involved in FDA-regulated investigations, and help[s] to ensure the reliability and integrity of the data used to support the marketing of products regulated by FDA."

According to FDA, the final rule was based on a recommendation from the General Accounting Office ("GAO") in September 2009. The GAO Report, Oversight of Clinical Investigators: Action Needed to Improve Timeliness and Enhance Scope of FDA's Debarment and Disqualification Process for Medical Product Investigators, stated that it was "critical for FDA to take action--and to have the authority to take action--to prevent clinical investigators . . . who engaged in serious misconduct from doing it again, whether in research that involve drugs, biologics, or devices." FDA is also amending its regulations for informal hearings under 21 C.F.R. Part 16 by changing the scope of certain provisions that were "inadvertently omitted."

FDA proposed the rule in the Federal Register on April 13, 2011 and received only two comments. FDA, however, managed to convert one of the filed comments to ten points to address in the preamble to the final rule. First, FDA clarified the "repeatedly or deliberately" language in the regulations for when a clinical investigator may be disqualified for repeatedly or deliberately failing to comply with FDA's applicable clinical investigations regulations or deliberately submitting false information to the sponsor. FDA said "repeatedly" means more than once, which can be more than one time in a single study or in more than one study. "Deliberately" means "willful" conduct or with reckless regard, such as knowingly failing to comply with FDA's regulations or falsifying data. In another point, FDA clarified that FDA will place no limits on how far back FDA will investigate to find applications or submissions that may have been affected by a disqualified investigator. In yet another point, FDA summarized the notification process for how sponsors become aware of an clinical investigator's ongoing disqualification process, including redacted letters on FDA's website. In the final point, FDA indicated how FDA notifies sponsors that clinical investigators have been reinstated--once again, primarily FDA's website.

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April 30, 2012

IOM Foreign Inspection Study Recommends How Developing Countries' FDA Counterparts Can Help

magnifying glass.jpgIn an effort to further investigate the position in emerging economies, FDA commissioned the Institute of Medicine ("IOM") to study and identify the core elements of food, drug, medical product, and biologics regulatory systems in developing countries with a view to identifying the main gaps in those systems and to design a strategy for FDA and other stakeholders, which can be used to strengthen the food and medical products regulatory systems abroad. FDA is under relentless pressure to increase the number of inspections it carries out of foreign medicinal product manufacturers. However, FDA cannot do this without help and without substantial improvements in the capacity of their counterpart agencies, particularly those in emerging economies.

The report compiled by the IOM Committee on Strengthening Core Elements of Regulatory Systems in Developing Countries and entitled "Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad" put forward several recommendations as to how the United States can play its part in helping strengthen the regulatory systems in low- and middle-income countries by promoting cross-border partnerships, including government, industry, and academia, to foster regulatory science and build a core of regulatory professionals. In putting together their report IOM staff travelled to China, Brazil, South Africa, and India to meet with regulators, representatives of regulated industry, academics, and health and development workers.

The IOM recommended that the FDA should use enterprise risk management to assist its inspection, training, regulatory cooperation, and surveillance efforts and should facilitate training for regulators in developing countries. The objective being workforce training and professional development through an ongoing, standard regulatory science and policy curriculum. The IOM stated that, "[E]nsuring the safety of food and medical products imported from around the world is a difficult task, and one that the FDA has executed fairly successfully so far. There is no reason to believe that their luck will hold over the next 10 years without substantive improvements in the capacity of their counterpart agencies abroad."

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