Lollipop device helps the blind see with the tongue

The FDA has cleared for marketing the BrainPort V100, an investigational medical device that people who are blind may use with a white cane or guide dog to perceive the location, position, size, and shape of objects, and to determine whether objects are moving or stationary. The  BrainPort V100 was reviewed by the FDA through the de novo premarket review pathway, a regulatory pathway for some low- to moderate-risk medical devices that are not substantially equivalent to an already legally-marketed device.

The battery-operated non-surgical device, manufactured by Wicab, Inc., of Middleton, Wisconsin, includes a video camera mounted on a pair of sunglasses that is connected to a small, flat lollipop-like device containing 400 electrodes that the user holds against the tongue. Software converts the image captured by the video camera into electrical signals that are sent to the lollipop device and felt as vibrations on the user’s tongue.

According to Wicab, the video camera works in a variety of lighting conditions and has an adjustable field of view. White pixels from the camera are felt on the tongue as strong stimulation, black pixels as no stimulation, and gray levels as medium levels of stimulation. Users of the device report the sensation as pictures that are painted on the tongue. A small hand-held unit about the size of a cell phone provides user controls and contains a rechargeable battery. With a minimum of 10 hours of supervised one-on-one training and experience, the user learns to interpret the signals to determine the location, position, size, and shape of objects, and to determine if objects are moving or stationary.

According to the FDA, the safety and effectiveness assessment of the BrainPort V100 included object recognition and word identification, as well as oral health exams to determine risks associated with holding the intra-oral device in the mouth. Clinical studies showed that 51 of the 74 subjects who completed one year of training were successful at the object recognition test. Some subjects reported burning, stinging or metallic taste associated with the intra-oral device. There were, however, no serious device-related adverse events reported.

Robert Beckman, CEO of Wicab, recently told Mobile World Live that he “is looking to mobile and wireless technologies to improve the company’s first-generation BrainPort V100 device.” Right now the device is not connected to the internet, explained Beckman. “[Through the use of wireless connections] we can eliminate the handheld controller and all the controls will be on the frame of the glasses, and we will wirelessly connect the device to mobile technology which will greatly expand the capabilities of the device.”

 

SCOTUS rules in favor of ACA subsidies for federal Exchange enrollees

In a six to three decision, the U.S. Supreme Court has affirmed the Fourth Circuit and upheld an Internal Revenue Service (IRS) ruling to extend health plan premium tax credits to individuals enrolled in Patient Protection and Affordable Care Act (ACA) (P.L. 111-148) coverage through a federal Health Insurance Exchange (Exchange). Chief Justice John Roberts, writing for the majority, and joined by Justices Kennedy, Ginsburg, Breyer, Sotomayor, and Kagan, found that the ACA phrase “an Exchange established by the state” did not expressly limit tax credits to state Exchanges, as alleged by the petitioners, but was properly viewed as ambiguous and that several other provisions in the ACA would make little sense if tax credits were not available to federal Exchange enrollees (King v. Burwell, June 25, 2015, Roberts, J.).

According to Roberts, “the fundamental cannon of statutory construction [is] that the words of a statute must be read in their context and with a view to their place in the overall statutory scheme.” Reading the words in the context of the ACA’s statutory scheme, Roberts wrote that the majority was compelled “to reject the petitioners’ [limited] interpretation because it would destabilize the individual insurance market in any State with a Federal Exchange, and likely create the very ‘death spirals’ that Congress designed the Act to avoid.”

Roberts granted that the petitioners’ arguments regarding the plain meaning reading of the language “an Exchange established by the state” were strong when viewed alone, however, “the context and structure of the ACA compelled [the Court] to depart from what would otherwise be the most natural reading of the pertinent statutory phrase.”

Justice Scalia, joined by Justices Alito and Thomas, wrote a scathing dissent claiming the majority changed the rules regarding statutory interpretation to save the ACA.

Background

The ACA’s subsidy provisions are the key instrument through which the Act makes coverage affordable to individuals who purchase insurance on an Exchange. The ACA provides for advance payment of premium tax credits for people with incomes between 100 and 400 percent of the federal poverty level (FPL, $11,770-$47,080 for an individual in 2015) and cost-sharing reductions for people with incomes from 100 to 250 percent of the FPL ($11,770-$29,425 per year for an individual in 2015). To illustrate the importance of the subsidy provisions, according to an HHS Assistant Secretary for Planning and Evaluation (ASPE) Issue Brief, in 2015, 87 percent of people who selected a plan in states with a federal Exchange received premium tax credits.

Section 1311 of the ACA is the provision that allows states to set up Exchanges and section 1321 requires the Secretary of HHS to set up federal Exchanges in states that fail to set up Exchanges. Under section 1401 of the ACA, individuals are offered premium assistance through tax credits if they meet certain requirements, including enrollment “through an Exchange established by the State under section 1311.”

Despite the plain language of section 1401, the IRS began issuing tax credits through both federal and state Exchanges in January 2014 (26 C.F.R. Sec. 1.36B-1(k); 77 FR 30377, May 23, 2012) (the “IRS Rule”). The IRS Rule provides that the credits will be available to anyone “enrolled in one or more qualified health plans through an Exchange,” and then adopts by cross-reference an HHS definition of “Exchange” that includes any Exchange, “regardless of whether the Exchange is established and operated by a State…or by HHS” (26 C.F.R. Sec. 1.36B-2; 45 C.F.R. Sec. 155.20).

The petitioners in Kingv. Burwell are Virginia residents who do not want to purchase comprehensive health insurance. Because Virginia has declined to establish a state Exchange, it is served by a federal Exchange. The petitioners claimed that the cost of the least expensive unsubsidized Exchange plan through the federal Exchange would exceed 8 percent of their 2014 income, making them exempt from the ACA tax for failing to comply with the individual mandate. However, if the IRS Rule was correct and premium tax credits were applicable to federal Exchanges, the reduced costs of the policies available to the petitioners would subject them to the minimum coverage penalty. Therefore, if Court upheld the IRS Rule, the petitioners contended they would incur some financial cost because they would be forced to either purchase insurance or pay the individual mandate penalty. The petitioners alleged that the ACA’s statutory language precluded the IRS’s interpretation that the premium tax credits are also available to federal Exchanges.

It was correctly thought that this case would turn on the ACA language that ties the amount of tax credits to a health plan purchased “through an Exchange established by the State.” The petitioners argued that this language is unambiguous and clearly means that persons who purchased their health insurance plan through a federal Exchange do not qualify for tax credits. The government disagreed with the petitioners’ interpretation of the language, arguing that even if the language is unambiguous, the IRS ruling to extend the tax credits to federal Exchange enrollees was reasonable and entitled to deference.

Court Rulings Below

On February 18, 2014, the U.S. District Court for the Eastern District of Virginia dismissed the petitioner’s complaint, finding that the IRS Rule was a permissible exercise of administrative discretion because the ACA as a whole clearly evinced Congress’s intent to make the tax credits available in both state and federal Exchanges (see Subsidies for health coverage through Exchanges within authority of IRS, Health Reform WK-EDGE, February 26, 2014).

On July 22, 2014, a three-judge panel of the Fourth Circuit unanimously affirmed the district court’s ruling that the IRS Rule was a permissible exercise of administrative discretion, finding that the applicable statutory language was ambiguous and subject to multiple interpretations (see Appellate court creates circuit split by upholding IRS Rule, Health Reform WK-EDGE, July 22, 2014).

That same day, however, in Halbig v. Burwell, the U.S. Court of Appeals for the District of Columbia Circuit reached the opposite conclusion, with its three-judge panel ruling 2-1 that the IRS did not have the authority to rewrite the wording of the ACA to suit its intent to allow federal Exchange subsidies (see Federal appeals court axes subsidies for federally-run Health Insurance Exchanges, Health Reform WK-EDGE, July 22, 2014).

The White House then filed a motion for rehearing of the Halbig ruling before a full panel of the D.C. Circuit, which has seven judges appointed by Democratic presidents and four appointed by Republicans (see Halbig panel was wrong; Government seeks rehearing to avoid ‘perverse consequences’, Health Reform WK-EDGE, August 6, 2014). The plaintiffs in Halbig opposed the government’s motion for rehearing by the full D.C. Circuit, claiming that the plaintiffs in King v. Burwell had already petitioned the Supreme Court for review in that factually related case (see Halbig team asks to skip straight to SCOTUS, Health Reform WK-EDGE, August 20, 2014).

The D.C. Circuit granted the government’s motion for a rehearing of the Halbig appeal by the full panel of judges (see Halbig decision on premium subsidies to be reheard by full D.C. Circuit, Health Reform WK-EDGE, September 10, 2014); however, after the Supreme Court agreed to hear King v. Burwell, the D.C. Circuit ordered that Halbig be removed from the oral argument calendar and held in abeyance pending the Supreme Court’s decision in King v. Burwell (see Federal court waits for SCOTUS to rule on health insurance subsidy, Health Reform WK-EDGE, November 19, 2014).

Supreme Court Briefs and Oral Arguments

In their Supreme Court brief, the petitioners argued that there is no legitimate way to construe the phrase “an Exchange established by the State under section 1311” to include one “established by HHS under section 1321.” Therefore, because Congress expressly provided tax credits only for state Exchanges, and not federal Exchanges, the petitioners contended that the Court must give effect to that plain meaning of the ACA. The government’s brief countered that the ACA text, structure, and history demonstrate that tax credits were meant to be available through both state and federal Exchanges.

On Wednesday, March 4, 2015, the U.S. Supreme Court heard oral arguments in the case. As expected, the Justices’ questioning indicated that the Court was split, with the liberal Justices dominating the questioning during petitioner’s portion of the argument, and the conservative Justices becoming more vocal once the government began its argument (see SCOTUS hears King v. Burwell: Kennedy voices constitutional concerns, Roberts doesn’t tip his hand, Health Reform WK-EDGE, March 5, 2015).

Majority Analysis

In its analysis, the majority recognized that the ACA involves three interlocking reforms in the individual health insurance market: (1) it bars preexisting conditions in determining whether to provide coverage (the guaranteed issue requirement) and in setting the premium (the community rating requirement); (2) it requires each person to maintain insurance coverage or make a payment to the IRS; and (3) it gives tax credits to certain people to make insurance more affordable.

In addition to the three interlocking reforms, the ACA required the creation of Exchanges by the states or by federal government if the states declined to do so. If the states declined, the ACA ordered HHS to establish “such Exchange.” According to the majority, the use of the words “such Exchange” indicated that the state and federal Exchanges should be treated the same and that would include the availability of premium tax credits. To rule otherwise would fly in the face of several other ACA provisions, such as the requirement that all Exchanges “distribute fair and impartial information concerning…the availability of premium tax credits.” This provision would not make sense, according to the majority, “if tax credits were not available on Federal Exchanges.”

The majority ultimately decided that the phrase “an Exchange established by the state” was ambiguous. They attributed the ambiguity to Congress (1) writing key parts of the ACA behind closed doors; and (2) passing much of the ACA through the reconciliation process, which limited opportunities for debate and amendment and bypassed the Senate’s normal 60-vote filibuster requirement.

Bearing in mind that statutes must be read in their context and with a view toward the overall statutory scheme, the majority rejected the petitioners’ plain meaning construct because it would destabilize the individual market and likely create “death spirals.” The majority determined that under the petitioners’ reading, the ACA’s three interlocking reforms, particularly the tax credit and coverage reforms, would not work in a meaningful way. The majority noted several studies, including one that predicted that premiums could increase 47 percent and enrollment could decrease by 70 percent. “It is implausible that Congress meant the Act to operate in this manner,” the majority decided.

Roberts concluded by reminding us that “[i]n a democracy, the power to make the law rests with those chosen by the people…A fair reading of legislation demands a fair understanding of the legislative plan. Congress passed the [ACA] to improve health insurance markets, not to destroy them. If at all possible, we must interpret the Act in a way that is consistent with the former, and avoids the latter.”

Dissenting Opinion

In his dissent, Justice Scalia argued that “[u]nder all the usual rules of interpretation…the Government should lose this case. But normal rules of interpretation seem always to yield to the overriding principle of the present Court: The Affordable Care Act must be saved.”

Scalia offered up numerous sections of the ACA that sharply distinguish between the establishment of an Exchange by a state and the federal government and thereby undermine the majority’s interpretation. He also offered seven provisions that refer to the establishment of Exchanges by the states, which he claimed would be nullified by the majority interpretation.

Scalia also attacked the majority claim that the phrase “such Exchange” implies that federal and state Exchanges are same. To highlight what he saw as the majority’s error, Scalia offered Article I, Section 4, Clause 1 of the U.S. Constitution, which states:

The Times, Places and Manner of holding Elections for Senators and Representatives, shall be prescribed in each State by the Legislature thereof; but the Congress may at any time by Law make or alter such Regulations.

According to Scalia, “[j]ust as the [ACA] directs States to establish Exchanges while allowing the Secretary to establish ‘such Exchange’ as a fallback, the Elections Clause directs state legislatures to prescribe election regulations while allowing Congress to make ‘such Regulations’ as a fallback.” Scalia asks “[w]ould anybody refer to an election regulation made by Congress as a ‘regulation prescribed by the state legislature’? Would anybody say that a federal election law and a state election law are in all respects equivalent? Of course not. The word ‘such’ does not help the Court one whit.”

Scalia suggested that “[r]ather than rewriting the law under the pretense of interpreting it, the Court should have left it to Congress to decide what to do about the Act’s limitation of tax credits to state Exchanges.” According to Scalia, the majority opinion changes the rules of statutory interpretation for the sake of the ACA, and thereby “aggrandizes judicial power and encourages congressional lassitude.”

Genetic discovery leads to additional cholesterol-lowering drugs

On June 9, 2015, the FDA’s Endrocrinologic and Metabolic Drugs Advisory Committee (EMDAC) recommended by a vote of 13 to 3 the approval of the investigational therapy Praluent™ (alirocumab injection), submitted by Sanofi-Aventis U.S. LLC and Regneron Pharmaceuticals, Inc. under biologics license application (BLA) 125559, for the long-term treatment of adult patients with high cholesterol. While the FDA is not bound by the EMDAC recommendation, it usually follows the advice of its advisory committees. On June 10, the EMDAC considered the safety and effectiveness of BLA 12552, submitted by Amgen Inc. for its Repatha (proposed trade name) (evolocumab injection), and voted 15-0 to recommend Repatha for approval.

Alirocumab

Praluent (alirocumab) is proposed to reduce bad cholesterol (LDL) and increase good cholesterol (HLD) either in combination with a statin or as monotherapy including in patients who cannot tolerate statins.

Evolumcumab

Repatha (evolumcumab) is proposed to reduce bad cholesterol and to increase good cholesterol either in combination with a statin or statin with other lipid-lowering therapies, or alone, or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or alone or in combination with other lipid-lowering therapies in patients for whom a statin is not considered clinically appropriate. The committee will also discuss the safety and efficacy of evolocumab in patients at least 12 years of age with genetic disorders characterized by high cholesterol.

Genetics-based discovery

According to the New York Times, both drugs were designed to mimic mutations in a gene, PCSK9, which protects people from getting heart disease. Clinical results indicate that most people who are given the drugs have had their LDL cholesterol levels drop from 40 to 65 percent.

“The discovery of PCSK9 as a powerful regulator of cholesterol levels and cardiovascular disease was one of the most important human genetic advances of the last decade,” said George D. Yancopoulos, M.D., Ph.D., Chief Scientific Officer of Regeneron and President, Regeneron Laboratories. “Today’s outcome brings us one step closer to translating this genetics-based discovery into a treatment that may help the many patients in need of additional cholesterol lowering.”

The view of committee experts

The Times reports that committee experts who voted not to recommend approval wanted to wait until they had results from larger clinical trials that better established the effectiveness of alirocumab. They also were concerned that clinical trial participants would drop out of the trials once the drugs were approved so they could be sure they were getting the actual drug and not a placebo.

The Times also reports that some of the experts were only comfortable recommending approval for people with genetic disorders characterized by high cholesterol, that are unable to control their cholesterol level with statins alone. Other experts favored allowing use of the drug by the much larger group of people at high risk of heart disease for whom statins are insufficient, according to the Times.

Cost of the drugs

The Times states, according to Dr. William Shrank, chief scientific officer at CVS Health, that because the drugs are monoclonal antibodies, produced from living cells at great expense, they will cost between $7,000 to $12,000 a year. In addition, the Times reports that Shrank believes: (1) if the drugs are restricted to people with high cholesterol levels who cannot get their LDL low enough with statins, the annual cost would be $16 billion; (2) if people who are intolerant to statins are included, the annual cost would be $36 billion; and (3) if people with a history of heart disease are included, the annual cost could be $166 billion.

The EMDAC has made briefing documents for both products available to the public:

 

FDA informs doctors of rogue distributors, offers drug purchasing tips

To reduce the threat to patients posed by unapproved, counterfeit, or otherwise unsafe prescription drugs, the FDA has issued letters to doctors who may have obtained these drugs from a rogue distributor. In addition to warning about the rogue distributors, the letters also contain tips on how doctors can avoid purchasing drugs that: (1) are fake, contaminated, ineffective, or otherwise unsafe; (2) have not been approved as safe and effective by the FDA; (3) do not contain the appropriate amount of active ingredients; (4) contain harmful ingredients; (5) were not manufactured using quality manufacturing processes; or (6) were stored under improper conditions.

These letters are part of the FDA’s “Know Your Source” program, which works to inform doctors about how to protect their patients from unsafe drugs. Here is a list of the most recent letters:

  • On April 1, 2015, the FDA sent more than 300 letters to medical practices that may have purchased unapproved prescription drugs, or unapproved injectable devices, from a foreign supplier, Gallant Pharmaceutical International, Inc., also known as Gallant Medical International, Inc.
  • On July 11, 2013, the FDA sent approximately 250 letters to medical practices that purchased Botox® from “Online Botox Pharmacy,” “Onlinebotox.com,” and “Onlinebotox.” The medication’s outer carton was counterfeit, while the vial inside was labeled as a foreign version of Botox.
  • On May 13, 2013, the FDA sent more than 1,000 letters to medical practices that may have received prescription drugs from Pharmalogical, Inc., d/b/a Medical Device King, that contained a counterfeit version of Altuzan (bevacizumab) that had no active ingredient. Bevacizumab is approved in the U.S. as Avastin®, and sold by Genentech, Inc.

Many of the distributors of these unsafe drugs have had criminal actions brought against them.

Growing trend

Ilisa Bernstein, Pharm.D., J.D., Deputy Director of FDA’s Center for Drug Evaluation and Research’s Office of Compliance, says she has seen a “growing trend of health care professionals and medical practice administrators who purchase prescription drugs from rogue wholesale drug distributors outside of the legitimate supply chain.” Bernstein offers a number of tips for doctors:

  • If an offer sounds too good to be true—it probably is. Deep discounts may indicate that the products are stolen, counterfeit, or unapproved.
  • Doctors should ensure they are receiving FDA-approved prescription drugs.
  • Only purchase from state-licensed wholesale drug distributors.
  • Check to see if the packaging, labeling, warnings, and dosing recommendations differ in any way from the FDA-approved packaging, labeling, warnings, and dosing for the product.
  • If several patients report that they are experiencing a new side effect or lack of therapeutic effect from the same product, consider that the drug may be substandard or counterfeit.

New tracing, verification, and identification system

The FDA is also working with prescription drug manufacturers, wholesale distributors, repackagers, and dispensers to establish and implement a new system that allows product tracing, verification, and identification as drugs travel through the U.S. market. This effort is part of FDA’s implementation of the Drug Supply Chain Security Act (DSCSA)—Title II of the Drug Quality and Security Act signed into law on November 27, 2013. Under the DSCSA, doctors who dispense or administer prescription drugs are required to purchase their prescription drugs only from authorized trading partners licensed by or registered with the state or federal government.