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December 20, 2013

Antibacterial Soap Rule Proposed by FDA: Could your Antibacterial Hand Soap Be Doing More Harm Than Good--FDA Intends To Find Out

handsoap.jpgOn December 17, 2013, the FDA issued a Proposed Rule for consumer antiseptic wash drug products. Prior to this Proposed Rule, the last Tentative Final Monograph ("TFM") issued for antiseptic active ingredients was in 1994 (59 Fed. Reg. 31,402), which classified 22 active ingredients for over-the-counter ("OTC") antiseptic handwash use.

The new Proposed Rule affects manufacturers of antibacterial hand soap and hand and body wash products containing OTC antiseptic active ingredients for repeated daily use, to be used with water. Those products do not include hand sanitizers or wipes. Additionally, the Proposed Rule is only to evaluate consumer antibacterial products and not health care setting antibacterial products, which have distinct proposed use settings, target populations, and risks for infection.

The Proposed Rule requires manufacturers of antibacterial soaps and washes to: (1) demonstrate the products are safe for long-term daily use; and (2) demonstrate with clinical data that the products are more effective than plain soap and water in the prevention of illness and the spread of infection. The manufacturers have one year to submit new data demonstrating that safety and effectiveness. If a manufacturer cannot demonstrate those two requirements, then it will have to reformulate the product (remove the antibacterial active ingredient).

Continue reading "Antibacterial Soap Rule Proposed by FDA: Could your Antibacterial Hand Soap Be Doing More Harm Than Good--FDA Intends To Find Out" »

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 19, 2012

OTC Advertising Study Finds Adverse Events Overly-Minimized

generic-drugs.jpgA research letter published online in the Journal of the American Medical Association ("JAMA") last Tuesday reports findings that pharmaceutical advertisements have a tendency to minimize potential adverse effects when the products they promote become available over-the-counter ("OTC"). The researchers attribute this shift in content to the differences in prescription drug advertising standards, governed by FDA, and those for OTC advertising, governed by the Federal Trade Commission ("FTC"). FDA requires that ads present a "fair balance" of the risks and benefits of a drug, a requirement that is absent from FTC's "reasonable consumer" standard. Commentators note that the FDA regulations are better equipped to ensure against "active deception."

The research endeavor, sponsored by CVS Caremark, considered four drugs that transitioned from prescription to OTC status within the last ten years: Claritin® (loratidine), Prilosec® (omeprazole), Xenical®/Alli® (orlistat), and Zyrtec® (cetirizine). It examined 133 total television and print advertising materials from twenty-four months prior to, through six months after, each transition, and found that the percentage of advertisements that referenced side effects plummeted from 70% while prescription only to 11% once available OTC. Conversely, the proportion describing drug benefits jumped from 83% to 97%. The study further reports that OTC advertisements frequently omit the generic names of drugs, "a powerful tool for the patient as a consumer in that it helps tie together scientific information on the drug from different places." Roughly 50% of the OTC ads mentioned the generic name, while over 95% had when the drugs were available by prescription only.

Written by Rachael P. McClure

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"In many, many cases information about risks simply disappeared from the ads once the drugs became [OTC]," remarked head researcher Dr. Jeremy Greene. This likely contributes to erroneous consumer beliefs that relocation out from behind the pharmacy counter automatically indicates a safer product. With 106 ingredients, indications, or dosage strengths having made the Rx-to-OTC switch since 1976, it is unlikely that this is always the case. Greene highlighted the danger of this situation given the frequency of overdoses on some of the most commonly used OTC drugs, such as acetaminophen (Tylenol®) and ibuprofen (Advil®). A 2006 study, for example, estimated over 450 acetaminophen overdose-related fatalities each year.

This research raises the question of where consumers can turn to obtain important information on potential side effects, if they are not receiving it from product ads or prescribers/suppliers. While some information is available online (such as at or, tracking it down requires active effort. Consumer Healthcare Products Association (CHPA) policy does note that the OTC label "is the most important element of a nonprescription drug," and "clearly lists a product's active ingredient, purpose, uses, warnings, directions, other information, and inactive ingredients." In an age dominated by electronic media, however, consumers are inevitably paying more attention to television and online/print advertising than drug labels. Also of note is that current OTC labeling requirements were promulgated by FDA, not FTC.

The Caremark study findings indicate that reform may be necessary to ensure transparency of consumer risks in the OTC pharmaceutical market, whether it be FDA oversight of OTC drugs or FTC adoption of stricter advertising criterion. With 240 million Americans currently using OTC medicines, according to a January 2012 CHPA report, it is a matter that deserves serious consideration.

May 25, 2012

Over-the-Counter Drug "New Paradigm" Coming--FDA Urges Patience

IMG_0148.JPG On May 11, FDA reportedly told attendees of the Consumer Healthcare Product Association's Regulatory & Scientific Conference in Washington, D.C. to be patient while FDA implements its "new paradigm" for prescription to over-the-counter ("Rx-to-OTC") switch applications (The Tan Sheet (May 21, 2012). Andrea Leonard-Segal, M.D., Director, Division of Nonprescription Clinical Evaluation, Office of Nonprescription Products, Center for Drug Evaluation and Research, said that FDA's anticipated, revised Rx-to-OTC regulations will allow for expanded conditions of safe nonprescription use.

Leonard-Segal acknowledged, however, that the process will take time, warning "if you submit [a new drug application] where we don't have the regulations to support the switch, if you're ahead of your time compared to the regulations, then I think the project won't go where you want it to go." While waiting for FDA to final the regulations, Leonard-Segal suggested that firms make business decisions about initiating switch programs that employ new diagnostic technologies and other measures, according to their internal estimate project timelines. Leonard-Segal, however, sympathized with sponsors that had failed to meet FDA's current, less flexible regulations that only permit OTC conversions where the Drug Facts label has full comprehension. An example of failed Rx-to-OTC switches cited was statins to lower cholesterol, but other categories of products that may benefit from the new regulations are sleep aids and triptans to treat migraines.

Commenting further, Leonard-Segal said at the Conference: "One of the frustrations of being in the switch business . . . has been watching the regulations interfere with, what in my perspective have been some very interesting and very innovative ideas, but that just can't move forward because the regulations don't allow us to go there." Leonard-Segal further noted that a priority for the new regulations will be to consider how diagnostic devices could work together with OTC drugs, which is currently a complex approval process involving multiple centers and considerations.

Continue reading "Over-the-Counter Drug "New Paradigm" Coming--FDA Urges Patience" »

March 29, 2012

OTC Drug Expansion Considered by FDA

by Kyle Deighan

IMG_0148.JPGFDA is currently exploring the possibility of allowing additional drugs for common health conditions to be sold over-the-counter ("OTC") without a prescription. FDA held public hearings last week to gather input from various groups on the issue, including consumers, pharmacists, and health care community members. Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research ("CDER"), explained, "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?" Drugs that may soon be available OTC without a prescription include cholesterol, asthma, migraine and blood-pressure medications.

FDA may require special conditions to apply before a drug may be sold OTC. These could include requiring patients to speak with a pharmacist before obtaining a medication or undergoing some form of diagnostic test. Or patients may be required to first see a physician to obtain a prescription, but then could obtain refills without needing subsequent prescriptions. FDA has also discussed the use of kiosks in pharmacies or questionnaires on the Internet to help consumers determine whether or not to take a certain drug. Woodcock noted that "the rules for nonprescription status were established in an age when widespread access to information technology did not exist. The world is evolving. It is clear there are now many interactive mechanisms that can help consumers through the process of self-diagnosis and medication selection in a much more comprehensive manner than a few worlds on a fact box."

Supporters argue that making more drugs available OTC would give patients the access they need to necessary medications. According to FDA, the time and cost required to visit a doctor, obtain a prescription, and then fill that prescription may deter patients from ever obtaining medications. An estimated 20 percent of patients with prescriptions do not even bother getting them filled, for example. Proponents argue that more OTC offerings would provide these patients with easier access to necessary drugs. Other benefits highlighted by FDA include "an increase in the appropriate use of medication, decreases in health costs, greater access to health screening ... and better, more consistent treatment of common conditions."

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January 3, 2012

Medication Errors Continue as FDA Issues Troubling Warning to About Ongoing Confusion Between Approved Eye Medicine and Unapproved Wart Remover

by Kyle Deighan

prescription.jpgLast week, FDA warned health care professionals to exercise caution when dispensing the FDA-approved eye medicine DUREZOL® (difluprednate ophthalmic emulsion) 0.05% and the unapproved prescription topical wart remover DURASAL® (salicylic acid) 26%. This comes after several reports of injuries caused when patients expecting to receive DUREZOL®, the eye medicine approved for the treatment of inflammation and pain associated with ocular surgery, were inadvertently given DURASAL®, an unapproved wart remover. One such incident resulted in a $1 million lawsuit against Walgreens, filed by a man who put the acid wart remover in his eye after ocular surgery. Although the packaging contained the explicit instructions "not for use in eyes," the man was using the eye drops to recover from eye surgery and was likely unable to read the warning. Perhaps the most troubling aspect of this story is that reports regarding possible confusion between DUREZOL® and DURASAL® go as far back as 2009.

In its report last week, FDA cautioned that pharmacists should exercise care when filling prescriptions for the eye medicine due to the potential for confusion between the names of the two medications. Obviously, this highlights a concerning issue that can arise with drugs that do not undergo the standard FDA approval process. Generally, as part of the drug approval process, FDA screens the proprietary names of proposed drugs for similarities with other products on the market. However, DURASAL® (the wart remover), did not undergo FDA's approval process, and was not screened to evaluate potential name confusion with other approved products prior to entering the market. As we have written about previously (such as here), thousands of unapproved drugs remain on the market (including over-the-counter ("OTC") drugs that also do not undergo a pre-approval process but are legal if they follow FDA's monographs) and problems such as this continue to crop up. FDA encourages health care professionals and patients to carefully examine packaging and labeling to avoid confusion.

As for DURASAL®, according to FDA, Elorac Inc., the distributor of DURASAL®, has not responded to requests from FDA to remove the product from the market or recalled the product from shelves. DURASAL® contains an active ingredient approved for wart removal but in an amount that exceeds the maximum concentration permitted for an OTC drug, which is why it is an unapproved drug. Interestingly, Elorac Inc.'s website does not list DURASAL® as one of its products, yet information about DURASAL® is still available through Elorac when the page is accessed. Elorac continues to manufacture another product containing salicyclic acid in a slightly higher amount and in a different vehicle called VIRASAL®, which also does not appear to have FDA approval, based on FDA's list of approved drugs. Both DURASAL® and VIRASAL® state on their prescribing labeling "Rx only / FOR TOPICAL USE ONLY. / NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE", which explains in part why some pharmacists may have been confused given that both DUREZOL® and DURASAL are labeled as prescription products.

Continue reading "Medication Errors Continue as FDA Issues Troubling Warning to About Ongoing Confusion Between Approved Eye Medicine and Unapproved Wart Remover" »

September 14, 2011

Homeopathic Drugs Remain Unregulated by FDA -- Why Petitioners Ask

by Fitz Beckwith Collings

The Center for Inquiry ("CFI") and its affiliate, the Committee for Skeptical Inquiry ("CSI") - want to know why FDA has not yet regulated the labeling and sale of homeopathic drugs. On August 26, the organizations jointly filed three citizen petitions requesting that FDA "require all commercially available drugs to be proven effective and be adequately labeled for their intended uses."


While homeopathic remedies have been on the market for some time, their use has become more widespread in recent years. Sales in the U.S. are approaching $1 billion, and CFI believes that this money would be better spent on remedies that have been proven as safe and effective as allopathic drugs. With flu season arriving, CFI's petitions specifically target homeopathic drug manufacturer Boiron and its flu-treatment drug, Oscillo--the "#1 Pharmacist Recommended Brand" despite the Centers for Disease Control and Prevention's ("CDC's") insistence that there is no scientific evidence that any homeopathic remedies have any benefit against influenza.

In its statement of grounds, CFI alleges that homeopathic drugs are no more effective than placebos. CFI asserts that the principles underlying homeopathy, which correlate increased dilution with increased effectiveness, result in over-the-counter ("OTC") homeopathic drugs that are actually devoid of active ingredients. In a typical "24X" homeopathic preparation, for example, the "active" ingredient is diluted 1:10 24 consecutive times and the resulting drug contains (on average) not one molecule of the "active" ingredient. Boiron's Oscillo product, by comparison, is a "200C" preparation (200 consecutive 1:100 dilutions), which CFI points out would contain only one molecule of the "active" ingredient in a volume more than 30 billion times the size of Earth.

Continue reading "Homeopathic Drugs Remain Unregulated by FDA -- Why Petitioners Ask" »

August 31, 2011

UK Over-the-Counter Painkiller Nurofen Plus Recalled in Suspected Sabotage

By Howard Rosenberg


Last week saw five reported cases of other manufactures' drugs being found in Nurofen Plus packets. The anti-psychotic Seroquel XL had been found in four packets of Nurofen Plus in England and Neurontin, a prescription medicine for epilepsy, had been found in one packet of Nurofen Plus bought from an independent pharmacist in Northern Ireland.

As a consequence Reckitt Benckiser (UK) has now stopped the manufacturing of Nurofen Plus and its distribution has been halted across the UK.

Reckitt Benckiser, recalled the product on Friday night and halted distribution after discovering the issue. The firm estimated 250,000 packets were in customers' hands.
Dr Aomesh Bhatt, medical director for Nurofen Plus said: "We are taking this matter extremely seriously and have decided to recall all packs of Nurofen Plus as the most prudent course of action in the current circumstances."

The UK's health authority, Medicines and Healthcare products Regulatory Agency (MHRA) has issued a class 1 drug alert to healthcare professionals, including General Practioners (GPs).

Continue reading "UK Over-the-Counter Painkiller Nurofen Plus Recalled in Suspected Sabotage" »

June 20, 2011

Suncreen Guidance Provided by FDA in New Proposed Rules

by Erin A. Lawrence

sunscreen.jpgAfter 33 years of consideration, FDA finally plans to reduce consumer confusion related to the ample types of sunscreens available on the market. On Tuesday, June 14, FDA published new guidance that will specify which lotions provide the best protection against the sun.

The new rules require sunscreens that claim protection against skin cancer to prove that they filter out UVB and UVA rays. Currently, FDA only requires testing for UVB rays--the ultraviolet rays responsible for sunburn and cancer. UVA rays are responsible for wrinkles and cancer.

Next summer, sunscreens that do not protect against UVA and UVB rays or if they are below a protection factor of 15 are required to carry the warning: "This product has been shown only to help prevent sunburn, not skin cancer or early skin aging." Consumers should be on the look out for sunscreens that state protection against a "broad spectrum." By next summer, this will mean that the lotion does an acceptable job at protecting against UVA and UVB rays. Lotions that protect against "broad spectrum" and are above SPF 15 will be allowed to state that they reduce the risks of cancer and signs of early aging if used as directed.

The new rules also propose several other changes. Sunscreen marketing claims like "waterproof" or "sweat proof" are prohibited, as the agency believes that these "are exaggerations of performance." The new rules required that a lotion past a water resistance test to maintain a water claim on their label. Additionally, FDA also proposes capping the highest SPF value at 50, unless the company can provide results of testing to support better protection. FDA reasoned that there is currently no data that shows that SPF above 50 adds any value. SPF stands for sun protection factor. The SPF number relates to protection against UVB rays.

All in all, consumers will have a much easier time deciding what lotion will keep their skin safe and healthy next summer. The must only look for sunscreen that claims "broad spectrum" and then the SPF that is over 15 of their choice.

May 18, 2011

OTC Push Toward Self-Diagnosis

by Erin A. Lawrence

pills.jpgWhat would the world be like if we had the ability to determine our own illnesses without visiting a doctor? Well, a subsidiary of the Advanced Medical Technology Association, called AdvaMedDx, is looking to make genetic diagnostic tests available for use at home or in pharmacies and drugstores.

This technology would allow a consumer to self-diagnose and to choose over-the-counter ("OTC") drugs that better meet their needs. AdvaMedDX's ideas include kiosks at drug stores and pharmacies that are capable of analyzing a consumer's saliva. Not only will such an advancement save time for the consumer, it will also likely lead to more drugs being OTC rather then prescription, because it would overcome concerns related to potential errors due to self-selection of medication. As recognized by Janet Woodcock, M.D., FDA Director of the Center for Drug Evaluation and Research, "The average consumer is not capable to determine whether they have [a certain] problem and then selecting an appropriate medication."

Advanced diagnostics will also be beneficial for consumer segments with specific genetic attributes. For instance, this could be used to create better skin care products or antiperspirants.

February 15, 2011

Plan B One-Step Emergency Contraceptive May Be OTC by New Years


otcdrugs.bmpOn February 8, Teva Pharmaceutical Industries ("Teva") announced in an earnings call that the previous day--a week before Valentine's Day--it had submitted to FDA a supplemental new drug application ("sNDA") to market its Plan B® One-Step (levonorgestrel) emergency contraceptive tablet as an over-the-counter ("OTC") drug product. Plan B® (two pills), which was first approved in 1999, contains a higher dose of the hormone progestin that has been used in traditional birth control pills for decades. Plan B® One-Step is indicated to prevent a pregnancy from occurring when taken as a single pill up to 72 hours after sexual intercourse. Plan B® One-Step is currently available without prescription for patients 17 years and older, when distributed by a pharmacist.

Teva's sNDA was long awaited by proponents, such as the Center for Reproductive Rights "CRR"), who had originally filed a citizen petition to open OTC access to Plan B® in 2001, when FDA had originally limited non-prescription sales to women 18 years and older. While FDA has not ruled on the petition--and reportedly did not plan to until Teva or another suitable applicant filed a request for OTC status--CRR subsequently filed a contempt complaint for FDA failing to reconsider OTC availability following a March 2009 court order to permit sales to women 17 years old. Teva's Plan B® One-Step was approved on July 10, 2009.

Teva's Plan B® One-Step sNDA is on a 10-month review timeline, which could permit its product to reach pharmacy shelves by the end of 2011--in time for the New Year. If Teva obtains approval for its sNDA, it will likely receive three years of market exclusivity for its OTC product, based on the clinical studies that it reportedly submitted to obtain OTC approval. In particular, Teva reportedly conducted studies for how females between the ages of 11 and 16 would self select an emergency contraceptive drug under simulated OTC conditions.

January 24, 2011

Deltex Pharmaceuticals and its Chief Executives Receive Permanent Injunction

by Laura Fanelli

DOJ3363886432_d6006337fb_z.jpgDeltex Pharmaceuticals, Inc., ("Deltex") of Rosenberg, Texas, is a manufacturer and distributor of prescription and over-the-counter ("OTC") drug products with a history of considerable regulatory violations. In 2008, after conducting inspections of Deltex's facilities, FDA issued a Warning Letter to Deltex for manufacturing unapproved drugs and for deviations from current Good Manufacturing Practice ("cGMP") regulations. However, after issuance of the letter, the company failed to modify its behavior. As a result, the U.S. Department of Justice filed a complaint detailing Deltex's violations of the Federal Food, Drug, and Cosmetic Act. Specifically, the complaint highlighted Deltex's failure to obtain necessary FDA approval for its prescription drug products, failure to comply with FDA's regulations governing OTC drug products, and failure to abide by cGMP requirements.

On January 18, FDA announced that the U.S. District Court for the Southern District of Texas entered a consent decree of permanent injunction against Deltex, its President, Kabir Ahmed, and Vice President, Mohidur R. Khan. Under the terms of the decree, the defendants cannot resume manufacturing and distributing any drug until Deltex complies with cGMP regulations. Further, the defendants cannot resume distribution of any drug product until it is approved by FDA or it complies with FDA's regulations governing OTC drugs. Additionally, Deltex must recall drugs that were manufactured and distributed since October 31, 2008--the date of FDA's Warning Letter--from their customers, destroy the recalled drugs, and advise their customers to recall products at the retail level. The decree additionally subjects the defendants to penalties of $2,500 per day if they fail to abide by any of the provisions of the decree, and an additional $500 for each violation.

In response to the injunction, FDA's Associate Commissioner for Regulatory Affairs, Dara A. Corrigan, said, "[t]his injunction shows that FDA will seek enforcement action against companies that are identified as being in violation of our manufacturing and drug approval requirements."

September 20, 2010

Nicotine Replacement Therapy Product Workshop Announced



On September 2, FDA announced a public workshop on October 26 and 27 to explore and solicit comments on the long-term use of nicotine replacement therapy (NRT) products.

NRT products are meant to help with smoking cessation by providing nicotine to lessen the effects of nicotine withdrawal for a maximum period of 12 weeks. NRT products are available as both prescription and over-the-counter products, in dosage forms as nasal sprays, oral inhalers, transdermal patches, chewing gum, and lozenges.

Some of the questions FDA plans to explore include whether long-term use of NRT products are safe and whether they help people to abstain from smoking or maintain reduced smoking levels. FDA wants to better understand whether it matters what dosage form is used and how this affects the potential for continued nicotine addiction. Unlike an advisory committee meeting, the purpose of the meeting is to obtain scientific input rather than make recommendations.

Earlier this year, several citizen petitions were filed requesting that FDA take a closer look at NRT products. In February, the Association for the Treatment of Tobacco Use and Dependence and the Society for Research on Nicotine and Tobacco filed a citizen petition requesting FDA to take a closer look at expanding the 12-week recommended limit for use of NRT products. More recently, on August 26, a jointly-filed citizen petition by the American Cancer Society Cancer Action Network, American Lung Cancer Society, Campaign for Tobacco-Free Kids, and the American Legacy Foundation asked FDA to reconsider its approach to approving new smoking cessation products, consider collaborating with manufacturers to develop more effective product development and clinical trial design for smoking cessation, and to reevaluate the labeling for current approved products. The petitioners also request that the evaluation of smoking cessation products be transferred from the Division of Anesthetics, Critical Care and Addiction Drug Products to the Office of Oncology Drug Products.

August 11, 2010

Drug Safety Bill Introduced in Congress


US capitol dome.jpgOn August 3, Senator Michael Bennet from Colorado introduced the Drug Safety and Accountability Act of 2010 (S. 3690), which was referred to the Committee on Health, Education, Labor, and Pensions. The Bill seeks to strengthen industry standards to ensure the quality and safety of drugs made for the U.S. market and to improve certain FDA oversight functions, such as improved tracking of foreign manufacturing sites and the power to order a drug recall (currently available for medical devices). In the end, the Bill could make U.S. drug manufacturers more diligent in monitoring the sources of the ingredients used in their drug products designed for U.S. consumers.

According to the Bill, the proposed legislative changes are required to address recurring manufacturing quality problems. Some of these problems include more than 1.3 million over-the-counter (OTC) children's medications recalled in 2010 for quality issues and up to 149 Americans dying in 2007 and 2008 from taking contaminated heparin from China. In addition, the Bill acknowledges that up to 80 percent of the active ingredients used in U.S. drugs come from overseas sources, where regulatory oversight standards differ from products made in the U.S.

The Bill seeks to provide FDA with better investigative tools for monitoring drug quality and safety. FDA would be granted the authority to assess civil penalties for violations of the Federal Food, Drug, and Cosmetic Act and to subpoena documents and witnesses. The Bill provides measures to facilitate the exchange of information between FDA and other regulatory bodies through mutual recognition agreements and improve the agency's ability to inspect non-U.S. manufacturing facilities that make drugs for the U.S. market. The Bill provides new or improved oversight for OTC drugs that have typically been considered a lower risk priority for the agency. In addition, the Bill provides measures to protect industry "whistleblowers", so they can provide FDA with additional regulatory information.

On the industry side, the Bill requires companies to establish quality management plans to ensure the quality and safety of their drugs. For example, companies would be required to better document the entities involved in producing the ingredients used in their drug products.