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Monday Morning Recap: The Week (1.27.14-2.2.14) in Drug & Device Law & Policy

Posted Feb 03 2014 12:00am
1. At Regulatory Reports, Alec Gaffney wrote an article, At 160 Million Patients, FDA’s Mini-Sentinel Isn’t so ‘Mini’ Anymore , in which he reports that “[a]s of July 2012, the Mini-Sentinel System’s Distributed Database (MSDD) includes information on 160 million individuals, 3.5 billion medication dispensingsmore than 45 million per monthand 3.8 billion unique medical encounters.”  According to Gaffney, Mini-Sentinel can already provide the FDA “with key information on the safety of products far more quickly than the agency could do by itself in the past. … In other words, thanks to big data, the only thing ‘mini’ about the Sentinel system may wind up being the waiting time between regulators asking a question and receiving an answer.”

2. An article in JAMA Internal Medicine, Nudging Guideline-Concordant Antibiotic Prescribing: A Randomized Clinical Trial , gives the results of a clinical trial that ”found a significant decrease in unnecessary antibiotic prescribing rates for patients treated by clinicians who signed and posted a letter in their examination rooms emphasizing a commitment to avoid inappropriate antibiotic prescribing for [acute respiratory infections].”  The authors comment that interventions grounded in a rational model of clinician behavior, such as education, electronic alerts, and financial incentives, ”have not been particularly effective.” They call for investigation of novel approaches, such as theirs, that appeal to psychological factors, such as our strong motivation to follow through on our publicly-made commitments.

3. On Thursday, January 30th, Dr. Jeffrey Shuren of the Food and Drug Administration’s Center for Devices and Radiological Health said at an event sponsored by the Pew Charitable Trusts that the FDA believes that there should be an expedited pathway to approval for high-need devices, paired with agency authority to order post-approval studies of devices, authority it already has with regard to drugs.  David Pittman reports on Shuren’s speech at MedPage Today, here .

4. Also on Thursday, CMS announced “interim financial results for select Medicare Accountable Care Organization (ACO) initiatives, an in-depth savings analysis for Pioneer ACOs, results from the Physician Group Practice demonstration, and expanded participation in the Bundled Payments for Care Improvement Initiative.  Savings from both the Medicare ACOs and Pioneer ACOs exceed $380 million.”  While less than half of the Medicare ACOs (54 of 114) that started in 2012 succeeded in cutting costs, CMS emphasized that the goal is “to achieve savings over several years, not always on an annual basis[.]“  The Pioneer ACOs also had inconsistent performance, with just 9 of 23 succeeding in cutting costs while maintaining quality.  The Pioneer ACOs nonetheless generated savings that ”far exceed findings from a previous analysis conducted by CMS, which used a different methodology.”

5. Finally, I highly recommend this  article  from last week by Jenny Gold at KHN News about how parents sharing information with other parents changed the standard of care for treating clubfoot.  Here’s a taste: “Surgeons are trained to operate…and usually that’s the way they make money. The Ponseti Method brings in a lot less for orthopedists. For about 50 years, technique mostly stayed in Iowa.  But then something new came along: The internet.”

Donna Hanrahan_Headshot (2) Advancements in information and communication technologies are fundamentally changing the way doctors and patients interact. These technologies, including electronic health records (EHRs) and mobile health (mHealth) tools, are transforming the industry and driving stakeholders across the healthcare landscape to reevaluate and transform how they provide services. mHealth holds promise for catalyzing improvement along the healthcare value chain, thus maximizing professionals’ time and productivity and improving the quality of care. Moreover, mobile health technologies have great potential to drive patient engagement and promote “ patient-centered care .”

The Health Information Technology for Economic and Clinical Health (HITECH) Act & “Meaningful Use”

Healthcare providers are incorporating healthcare technology and implementing electronic health record (EHR) systems at an accelerated rate in recent years, largely due to the Health Information Technology for Economic and Clinical Health (HITECH) Act. The HITECH Act was created as a part of the American Recovery and Reinvestment Act of 2009. The $27 billion dollar piece of legislation offers eligible providers incentives for expanding the use of healthcare information technology. This includes promoting the “meaningful use” of EHRs. The “meaningful use” standard was designed for physicians to use technology to improve quality of care and health outcomes for patients, as well as to lower costs by eliminating repeat medical tests and reducing preventable medical errors that pervade the health-care system today. This legislation has been extremely effective in persuading healthcare providers to use electronic health records. EHRs, in conjunction with other healthcare information technologies such as mobile health (mHealth) tools, have vast potential to improve patient health by promoting patient-centered care.

The HITECH Act offers eligible healthcare professionals and hospitals incentives for expanding the use of healthcare information technology and meeting the “meaningful use” requirements, namely electronic health records. The Department of Health and Human Services (HHS) defines meaningful use as using certified healthcare information technology: (1) to improve quality, safety, efficiency, and reduce health disparities; (2) to engage patients and families; (3) to improve care coordination, and population health; and (4) to maintain the privacy and security of patient health information. The “meaningful use” framework incentivizes enhancement of clinical care and quality by encouraging healthcare professionals to take advantage of instantaneous and patient-specific information. Incentive payments are made available through the Medicaid and Medicare programs. Eligible professionals and hospitals that meet the criteria can be rewarded up to $44,000 in Medicare and $63,750 in Medicaid payments over 5 years. After 2015, physicians who fail to meaningfully use EHRs will be subject to reductions in Medicare and Medicaid reimbursement. To receive payments, eligible professionals and hospitals must meet “meaningful use” criteria , including e-prescribing, patient-specific health education, and the use of drug interaction software to ensure patient safety.

Unlocking the Value of Mobile Health Technology in Healthcare Settings

Mobile health applications connect patients with providers, coordinate care, and promote self-management of health conditions. Smartphone and tablet applications are projected to be an efficient way to get patients involved in their care, help grow healthcare practices, and build trust between the physician and patient. One recent survey by eClinicalWorks suggests that 93% of physicians believe mHealth apps have the potential to improve patient outcomes and 89% are likely to recommend a mobile health app to a patient. Appointment scheduling applications, secure messaging platforms, and patient education tools have rich clinical and business value to modern medical practice.

Incorporating mHealth technologies benefit healthcare professionals, healthcare consumers, and the healthcare industry alike. For healthcare professionals, applying mobile technologies can help lower administrative costs, cultivate customer interactions, enhance customer service, boost business performance, and help meet stage 2 of the meaningful use requirements. For patients, mobile technologies can improve engagement and disease management, provide education, allow for self-monitoring, and guide users to facilities for appropriate levels of care. For the pharmaceutical and medical device industries, applying mobile technologies into marketing and outreach campaigns can serve to cultivate consumer interactions, boost business performance, enhance consumer trust by providing reliable and relevant information to patients, and importantly allow educated patients to advocate for certain aspects of their care. Accordingly, there is great value to unlock for all key stakeholders in the healthcare landscape to develop a core framework that involves the use of innovative mobile and digital technologies.

paradiseLGjpg_1 Debate continues regarding the Food and Drug Administration (FDA) proposed rule that would allow generic drug manufacturers to independently make changes to a drug label on the basis of newly acquired safety information.  The proposed rule trails a trilogy of Supreme Court decisions tackling questions of federal preemption in the pharmaceutical realm: Wyeth v. Levine (2009) , PLIVA v. Mensing (2011) , and Bartlett v. Mutual Pharmaceutical (2013) .  In Wyeth v. Levine (2009) , the Supreme Court held that the federal Food, Drug, and Cosmetic Act (FDCA) does not preempt failure to warn claims for brand name, also called reference listed drugs (RLD).  Taken together, and establish that the FDCA does, however, impliedly preempt both state tort law failure to warn and design defect claims against generic pharmaceutical manufacturers. 

Why such seemingly opposite results regarding preemption?  It’s the result of FDA regulations and the statute.  The regulations provide that RLD manufacturers are able to update product labeling prior to FDA review of the change in a changes-being-effected (“CBE-0”) supplement.  This mechanism originated from a 1965 enforcement discretion policy in which the FDA recognized that some labeling changes ought to be implemented as soon as possible in order to adequately protect consumers.  The procedure is now contained in 21 C.F.R. 314.70 , allowing RLD manufacturers to makes such labeling changes upon submission of a CBE-0 supplement in several circumstances, including the addition or strengthening of a contraindication, adverse reaction, warning, or precaution shown by newly-acquired or discovered scientific evidence. 

As for the statute, the Hatch-Waxman Act of 1984 amended the FDCA to create the abbreviated new drug application (ANDA), or generic drug approval process.  Approval of a generic drug product is based on the concept of bioequivalence, which means the generic is identical to the RLD for purposes of safety and efficacy.  The legislation explicitly requires that generic drug applicants must submit “information to show that the labeling proposed for the new drug is the same as the labeling approved for the listed drug…” FDCA §505(j)(2)(A)(v); 21 U.S.C. 355(j)(2)(A)(v).  Congress included this provision to facilitate the acceptance of these products by physicians, pharmacists, and patients, as well as ensure uniformity for bioequivalent products.  Identical labels also helped bolster substitution of generic drugs for brand name drugs as a means to impart cost-savings onto both the government and consumers.  Until the publication of the recent proposed rule, the FDA has maintained the position that the statute prohibits generic manufacturers from deviating from a label identical to that of the RLD, expressed in 57 Fed. Reg. 17950, 17961 (1992).

The FDA now proposes to add a provision to the regulation to bring parity to the RLD and generic realm in terms of the availability of the CBE-0 supplement for labeling changes.  The FDA acknowledges that the proposed rule would alter the long-standing policy that the labeling of generics must be identical to the RLD.  As support for the change in position, the FDA cites changed circumstances:

[A]s the generic drug industry has matured and captured an increasing share of the market, tension has grown between the requirement that a generic drug have the same labeling as its RLD, which facilitates substitution of a generic drug for the prescribed product, and the need for an ANDA holder to be able to independently update its labeling as part of its independent responsibility to ensure that the labeling is up-to-date.

An FDA press release further emphasizes that the generic share of the market is currently over 80% of U.S. prescriptions.  The proposed rule discusses , , and , noticeably understating that the rule “may” eliminate preemption for generic drugs.

Two years ago, legislators attempted such a change at the statutory level.  Companion bills, both entitled Patient Safety and Generic Labeling Improvement Act, were introduced in the House (HB 4384) and Senate (S 2295), which would have amended the FDCA to make the CBE-0 supplement available to generic manufacturers by law.  Both died.  The bill language read as follows:

(A) Notwithstanding any other provision of this Act, the holder of an approved application under this subsection may change the labeling of a drug so approved in the same manner authorized by regulation for the holder of an approved new drug application under subsection (b).

(B) In the event of a labeling change made under subparagraph (A), the Secretary may order conforming changes to the labeling of the equivalent listed drug and each drug approved under this subsection that corresponds to such listed drug.

Now, another group of legislators is taking a different stance.  On January 22, nearly 30 members of Congress signed a letter addressed to the Commissioner of the FDA, Dr. Margaret Hamburg, expressing “grave concerns” about the proposed regulation. The letter questions the authority to promulgate such a rule given the statutory language and urges that it would lead to inconsistency in drug messages to consumers and physicians alike.  The letter states that the proposed rule would “conflict directly with the statute, thwart the law’s purposes and objectives, and impose significant costs on the drug industry and healthcare consumers.”  The letter directs the Commissioner to answer 11 enumerated questions by February 5 in order to “assist the Committee(s) in better understanding the decision making process.”  Related press releases can be found here and here .

Many more are expected to chime in.  Originally scheduled to close mid-January, the FDA has extended the comment period until March 13, 2014.



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