November 11, 2002

**VIA E-MAIL (fdadockets@oc.fda.gov)**

**VIA FACSIMILE (301-827-6870) and**

**U.S. FIRST CLASS MAIL**

Dockets Management Branch

Food and Drug Administration

5630 Fishers Lane, Room 1061

Rockville, MD 20852

Re: Docket Number 02N‑0209\
Response to Comments on First Amendment Issues

Dear Sir or Madam:

The Indiana Medical Device Manufacturer's Council ("IMDMC") appreciates
this opportunity to submit this response to comments on the Food and
Drug Administration's (FDA) Request for Comment on First Amendment
Issues. IMDMC is an Indiana‑based trade association of about sixty
medical technology manufacturers and others in allied fields.

We support FDA's commitment to ensure that its regulations and policies
comply with the First Amendment, and we appreciate this opportunity to
provide our input on this significant regulatory reform initiative. We
realize the magnitude of FDA's undertaking, especially with regard to
the issues at stake. As with all First Amendment issues, not only does
regulation of the speech affect the rights of the "speaker," it also
affects the rights of the intended audience to receive the speech.

Moreover, we understand and respect FDA's charge to protect the public's
health and safety by ensuring that drugs and medical devices are safe
and effective for human use. This mission, however, must be consistent
with the First Amendment. On May 6, 2002, FDA published a request for
comments on First Amendment issues in the *Federal Register*, the
deadline for which was extended on July 10, 2002. FDA is now accepting
responses to the comments that were submitted, and IMDMC is pleased to
have this opportunity to express its agreement and disagreement with
selected comments. We group our responses into six categories.

# FDA Should Modify Its Present Stance Regarding Communications about Off‑Label Uses of a Drug or Device.

FDA should modify its present stance regarding off‑label communications
because it is inconsistent with the First Amendment. As Schering‑Plough
explained: "Currently, FDA holds manufacturers of prescription products
to a standard that requires any communication by those manufacturers
about their products, even scientific and medical information, to be
consistent with those products' FDA‑approved labeling."[^1] We concur
with the company's conclusion that "instead of being focused on the
approved labeling, FDA's restriction of commercial speech must be
focused on the truth of the messages being disseminated in order to be
constitutionally sound."[^2] Clearly, "it goes without saying that even
the currently approved package insert does not reveal everything that
may be *true* about a drug product."[^3] These principles are also true
for medical devices.

How, then, should FDA determine the truth of a communication? Presently,
FDA's method of determining whether something is "true" is to use a very
high evidentiary standard. For example, to say or imply that a drug or
device is safe and effective, in FDA's view the company must have two
"adequate and well‑controlled" clinical studies that support the
determination that the product in question is in fact safe and effective
for human use. In other words, according to FDA a company cannot claim
or imply that its product is "safe and effective" without these
supporting studies. Similarly, under its present regulatory stance, if
FDA deems a claim regarding a drug or device to contain an implied claim
that the product is safe and effective, FDA expects the company to have
this same level of evidence.

Importantly, we agree with that approach for those claims. But that does
not provide guidance on how other communications should be judged.
Because *Central Hudson* obligates FDA to use the "least restrictive"
means available to regulate commercial speech, FDA cannot make its
evidentiary standard for product approval into the standard of truth for
all statements. This is because the constitutional standard for
regulation of commercial speech---truthful and non‑misleading---for a
specific off‑label statement has to be judged by the facts and
circumstances surrounding the particular communication. Factors such as
(1) full disclosure of the data---favorable and unfavorable---and
(2) the avoidance of implied claims through the use of disclaimers
become very important to deciding whether a communication passes muster
under the First Amendment.

As already noted, we recognize that a blanket statement that a product
is safe and effective may be problematic if the safety and effectiveness
of the product has not been proven under the same evidentiary standard
as FDA applies in approving products. However, this is because such a
statement may mislead consumers to believe that the evidence necessary
to meet the approval standard exists. Thus, we believe that companies
should not be allowed to make such blanket claims of safety and
effectiveness unless the companies possess the evidence necessary to
meet the approval standard.

On the other hand, manufacturers should be able to communicate data so
long as they avoid making or implying a claim that a product is safe and
effective. To do so, they should make a statement (that accompanies any
communication regarding an off‑label use) that FDA has not approved the
product in question, and thus its safety and effectiveness has not been
established. Moreover, to prevent its audience from being misled, the
company should disclose enough relevant information about the off‑label
use, including positive and negative information, to achieve a fair
balance. If it does those two things, the statements will be truthful
and not misleading, especially if made to a sophisticated audience like
physicians (see part II of this comment). Such statements thus should
not be prohibited.

Comments advocating that FDA continue to equate the standard for product
approval with the standard for all communications about the product were
submitted by some members of Congress.[^4] The congressmen addressed the
topic of disclaimers, comparing the above‑described disclaimers to the
system of drug approval that existed before 1962. They asserted that a
disclaimer indicating that "a claim had not been reviewed by FDA would
provide no useful information to a physician about whether to prescribe
the drug and would offer her patients no protection from unsafe or
ineffective products, or from the harm that can flow from such
products. . . ."[^5] We respectfully disagree with this assertion. The
crux of this disclaimer is that it prevents the communication from
misleading physicians about the approval status of the product.
Physicians, as the "learned intermediaries" between the product and the
consumer, can then make an informed judgment about the appropriateness
of allowing a patient access to the product for the patient's particular
use. Truthful scientific information is a good thing.

Similarly, the congressmen criticize "a statement created by the
manufacturer ostensibly providing adequate information for a consumer to
assess the weight of the evidence supporting a claim."[^6] In
particular, the comments claim that companies will not conduct adequate
tests and will not provide an objective presentation of the existing
evidence.[^7] We also disagree with these assertions. First, if FDA
makes the rules of the road clear, the vast majority of companies will
act responsibly and follow them. And second, for those that don't, FDA
is perfectly able to enforce its rules. The risk that a few companies
will not follow the law can hardly be a reason for prohibiting all
speech. That is the essence of *Central Hudson*.

Because the First Amendment mandates that commercial speech be regulated
in the least restrictive way possible, FDA should permit companies to
communicate about off‑label uses of their products if an effective
disclaimer accompanies the communication, and if the company fully
discloses the basis for its statements with fair balance.

# The Role of Physicians Calls for More Latitude in Regulating Speech.

Several comments noted the important role that physicians play as the
audience for communications from manufacturers. As Johnson & Johnson
explained:

> Physicians are also required by ethics and laws governing professional
> practice to assert their best medical judgment in prescribing the most
> appropriate products for a patient, based on the condition, medical
> history, and circumstances presented by that patient. The physician,
> as a "learned intermediary," is the actor who possesses the greatest
> knowledge of the particular patient's needs, the medical and clinical
> knowledge of the patient's disease state, and the medical and clinical
> knowledge that will lead to the prescription of appropriate products
> to meet the patient's needs.[^8]

We would like to emphasize the need for a greater information flow to
that audience, and the legal basis for that latitude.

## Sound Policy Reasons Exist for a Freer Flow of Speech to Physicians.

While there are many advantages to moderating the impediments to sharing
information with health care providers, we have distilled those reasons
down to five important ones.

First, doctors and other health care providers have moral and licensing
obligations to exercise their professional judgment to provide the
highest quality care. To provide that care, doctors need the latest
information on the safety, effectiveness, and cost/benefit for all uses
of devices and drugs, including those uses that are unapproved. Using
governmental regulation to limit the flow of information from companies
to doctors runs counter to the moral and legal obligations that society
imposes on doctors to exercise their professional judgment in providing
care. From a basic public health standpoint, physicians simply need the
best and most recent information to provide the highest quality care at
the lowest cost. Conversely, the responsibility for those drug and
device selection decisions rests with the care provider, who cannot
properly exercise that professional charge without full information
access.

Second, like other sciences, medicine advances when physicians and other
scientists piece together existing information to develop new theories
that can be tested, thus producing new information. This system works
best when information flows freely. A piece of information in the hands
of a device or pharmaceutical company could be just the information
needed by a researcher across the country struggling to develop a cure
for a different disease. And, while some would challenge the objectivity
of device or pharmaceutical companies in presenting information, few
would dispute that companies know a great deal about the products they
make. For pharmaceutical companies, this is true if for no other reason
than because the company is required by regulations to provide annual
reports to FDA for all marketed products, which includes a summary of
all pertinent studies and publications relating to each drug.[^9]

Third, all truthful information on safety, effectiveness, and
cost/benefit has value that can be determined and weighed by a
sophisticated audience. Health care decisions must be made every day,
and these ought to be based on the best available information whether or
not that information is supported by "substantial evidence." Given the
rate of technological change, the need for information dissemination is
immediate. Society cannot afford for FDA to act as a gatekeeper for
information regarding products that FDA already has approved as safe and
efficacious.

Fourth, information sharing helps reduce inappropriate variation in
health care. It is well known that medical treatments vary widely, and
often without discernible cause. Sharing information allows health care
providers to target process defects and move toward the best,
standardized practices. At the same time, information can allow
physicians to exercise intelligent judgments about when variation is
appropriate for individual patients. In short, supplying health care
providers with fuller information than what is contained in the package
insert allows them to tailor treatments to the idiosyncrasies of both
individual patients and specific populations. Limitations on information
access confound this process.

Fifth, the unrestricted dissemination of credible information such as
treatment protocols and journal articles to health care providers by
companies streamlines the education process. It is not feasible for
doctors and other health care providers to read all journal articles by
individually subscribing. There are more than 30,000 medical journals in
the world for doctors to read, producing millions of pages each
year.[^10] Information, to be useful to physicians with little time for
reading, needs to be efficiently presented in a convenient vehicle.
Companies can provide this service by collecting and presenting
materials to physicians in a way that allows the doctors to gain a
quicker understanding of the important issues, and that also discloses
to physicians the regulatory status of the uses described in the
article. A patient should not be denied the latest care just because her
doctor does not happen to subscribe to the journal that published a
breakthrough article. Patients deserve the opportunity to benefit from
new observations, and such opportunity should not be dependent on
"happenstance" informational findings.

## A Sound Basis in Law Exists for Judging Such Communications Differently from Communications to Patients.

Courts have repeatedly held that compliance with section 502(a) of the
Federal Food, Drug, and Cosmetic Act ("FDCA")[^11] should be judged by
the meaning of the words to the audience to which the labeling is
directed.[^12] In line with that test, courts have interpreted
section 502(a) as imposing a higher burden for substantiation when the
audience is unsophisticated.[^13]

FDA has apparently embraced that interpretation of section 502(a)
because the agency has in several situations used section 502(a) as a
basis for requiring that labeling be tailored to the level of the
particular audience. A classic example is the agency's requirement of a
patient package insert that is tailored to the sophistication of
patients, in contrast to the professional labeling tailored to the level
of health care providers.[^14] For example, the agency currently
requires patient labeling for oral contraceptives and estrogen
products.[^15] When the agency earlier sought to impose a broad
requirement of a patient package insert tailored to the reading
comprehension of patients, the agency explained that professional
labeling could not fulfill the needs of most patients for understandable
information about prescription drugs because that labeling is too
technical for most patients to understand.[^16] The agency used
section 502(a) to justify an affirmative requirement of special labeling
tailored to the patient level.[^17] Thus, FDA apparently has already
concluded that section 502(a) requires that drug and device labeling be
tailored to the level of the audience.

By force of logic, the converse of FDA's conclusion that section 502(a)
requires special labeling for unsophisticated audiences must also be
true. That is, when an audience is particularly sophisticated, FDA needs
to take that fact into account when judging the appropriateness of
labeling directed at that audience. Part of that appropriateness is the
level of substantiation for the labeling and the disclosure of the
methods of research. Thus, section 502(a), *by FDA's own interpretation
and those of the courts*, compels the agency to adopt different
substantiation requirements for labeling depending on the sophistication
of the audience.

From a First Amendment point of view, while the federal government has a
substantial interest in the flow of information about devices and drugs,
FDA's current approach to regulating post‑approval information fails the
*Central Hudson* test because, among other things, it is more extensive
than necessary to serve the government's interest. FDA's current
overly‑broad regulatory approach censors the flow to *all* audiences of
post‑approval information not meeting the artificially high standard for
approving new products. FDA must therefore address the propriety of
applying the approval standard to information provided to highly trained
physicians. We think more latitude is required.

# FDA Should Revise Existing Regulations that Indirectly and Unconstitutionally Regulate Commercial Speech.

IMDMC is very concerned about the manner in which FDA uses some of its
existing regulations to indirectly regulate commercial speech. In
particular, we agree with AdvaMed's comments on FDA's "intended use"
regulation in 21 C.F.R. § 801.4:

> As drafted, the so‑called "catch 22" provision potentially conflicts
> with a manufacturer's ability to freely disseminate information about
> off‑label uses or unapproved product information contained in the
> peer‑reviewed journal article or abstract---effectively requiring the
> manufacturer to submit a marketing application to FDA for that
> off‑label or unapproved product upon dissemination of this type of
> information. This regulation should be revised to allow a manufacturer
> to disseminate truthful non‑misleading information without imposing
> restrictions on speech.[^18]

We agree with this statement and would like to elaborate on our concerns
relating to section 801.4. Section 801.4 provides that the "intended
uses" of a medical device:

> \[R\]efer to the objective intent of the persons legally responsible
> for the labeling of devices. . . . This objective intent may, for
> example, be shown by labeling claims, advertising matter, or oral or
> written statements by such persons or their representatives. It may be
> shown by the circumstances that the article is, with the knowledge of
> such persons or their representatives, offered and used for a purpose
> for which it is neither labeled nor advertised.

The regulation then goes on to require that for these uses, the
manufacturer must supply adequate labeling. But a manufacturer cannot
revise the labeling without getting it approved. Through warning
letters, FDA has used this section to regulate manufacturers' websites,
marketing brochures, journal advertisements, and other promotional
articles.[^19] In these letters, FDA warns the manufacturers to correct
these violations. Thus, through section 801.4, FDA makes it illegal to
communicate about an off‑label use.

As outlined in the prior section, we believe FDA should permit
communications about off‑label uses that are not false or misleading. To
permit that sort of communication, we believe FDA needs to amend
section 801.4 to not require labeling for off‑label uses.

FDA cannot use this regulation as an end‑run around the requirements of
the First Amendment.[^20] As the comments of PhRMA explained: "If the
agency cannot regulate speech directly under the full *Central Hudson*
test, it may not regulate it indirectly by using the speech as per se
evidence of unlawful conduct."[^21] As applied here, communication
regarding off‑label use falls under the rubric of *Central Hudson*
because it concerns truthful speech and is not misleading. Under
*Central Hudson*, FDA's use of section 801.4 is not the least
restrictive means for FDA to advance the agency's interest.

Indeed, as an alternative to the current approach, if FDA is concerned
about off‑label use of a device, it can require manufacturers to put a
warning on the device stating the uses for which FDA has approved the
device and specifically disclaiming that other uses have not been
approved. Warnings adequately advise consumers of the risks associated
with the use of a medical device, and they do not infringe First
Amendment rights.

In sum, *Central Hudson* does not permit FDA to directly prohibit
truthful commercial speech regarding off‑label use; nor can it do so
indirectly.

# FDA Should Recognize that Incentives Already Exist that Compel Manufacturers to Seek FDA Approval and to Communicate Only Truthful and Non‑Misleading Information about Off‑Label Uses of Their Product.

One reason FDA asserts for the prohibition of off‑label information is
the desire to create an incentive for companies to seek FDA approval.
Many comments disagreed, and we would like to add our experience to the
discussion. Our experience demonstrates that there already are
incentives for a company to seek FDA approval, and there are also
incentives to communicate only truthful and non‑misleading information
relating to off‑label uses of a product.

## The Potential Loss of a Preemption Defense Influences Companies to Seek FDA Approval.

Obviously marketing reasons influence companies to seek FDA
approval---it is a seal of approval that is widely respected in the
marketplace. Moreover, there is a marketing benefit to bringing a use on
label so that it gets attention from end users. But more than that,
there are legal reasons to seek FDA approval.

The potential loss of the defense of preemption in a product liability
action influences companies to seek FDA approval. In particular, the
1976 Medical Device Amendments contain an express provision that
preempts certain state requirements respecting a medical device.

> \[N\]o State or political subdivision of a State may establish or
> continue in effect with respect to a device intended for human use any
> requirement---

(1) which is different from, or in addition to, any requirement
applicable under this chapter to the device, and

(2) which relates to the safety or effectiveness of the device or to any
other matter included in a requirement applicable to the device under
this chapter.[^22]

FDA regulations interpret section 360k as preempting *any* requirement,
"whether established by statute, ordinance, regulation, or court
decision."[^23]

In addition, courts have interpreted section 360k as preempting state
express warranty claims that are based upon "FDA‑mandated labeling,
packaging, or advertising."[^24] In general, a state express warranty
claim holds a seller liable for making an affirmation of fact or a
promise that induces a buyer to purchase a product, but which the seller
ultimately does not fulfill.[^25] However, if a manufacturer‑defendant
fails to comply with FDA regulations governing medical devices, the
defendant can lose its preemption defense and be sued on the state
claim.[^26]

The preemption defense thus provides an incentive for manufacturers to
seek FDA approval and promote only on‑label uses of their device.
Because manufacturers realize that communications about an unapproved
use for a product may lead them into a product liability action for
which they have no preemption defense, they tend to seek FDA approval
and limit their communications to on‑label uses.

## Legal Liability Influences Companies to Communicate Only Truthful and Non‑Misleading Information Regarding Off‑Label Uses of Their Product.

Quite apart from regulatory requirements, the marketplace itself and the
civil liability system ensure honesty. The increased competition in the
drug and device industries acts as a self‑policing mechanism. History
suggests that device and drug companies closely scrutinize each other's
comparative claims. Thus, any false or misleading information would
undoubtedly be brought to the attention of the market by a competitor.
Companies taking liberties with the truth would lose their reputation in
the marketplace, which is perhaps the most devastating penalty of
all.[^27]

Moreover, drug and device companies also would have legal redress to
bring suit against each other for false advertising under section 43 of
the Lanham Act.[^28] And device and drug purchasers could sue
manufacturers that make false claims to induce a sale.[^29] All of these
mechanisms provide significant incentives for device and drug companies
to act with integrity as they make claims.

Many of the comments touched on product liability. We would like to
further elaborate on the significance of product liability as relating
to speech. In particular, we strongly believe that product liability
creates a strong disincentive to communicating false or misleading
information about off‑label uses of products.

A manufacturer can create liability for itself by overzealously or
irresponsibly marketing its product.[^30] Indeed, a manufacturer may be
liable if it "overpromotes" and "underwarns" a physician with regard to
a drug or device, even if a physician denies relying on the promotional
literature at issue.[^31]

Thus, to avoid potentially costly product liability actions,
manufacturers must not communicate an inaccurate or unbalanced view of
the state of information that exists with respect to a product. Indeed,
in some cases, the risk of losing this defense may even cause a
manufacturer to communicate only about approved uses for a product (and
to do so in a truthful and balanced manner).

# FDA Should Modify Its Stance on Scientific and Technical Information so that It Conforms with the First Amendment.

## FDA Should Recognize that Peer‑Reviewed Scientific and Technical Information Mandates More Protection than Commercial Speech and May Be Suppressed Only upon the Most Compelling of Circumstances.

Many comments expressed deep concern regarding FDA's present regulatory
stance on the dissemination of scientific and technical information. We
share this same concern. In particular, we believe that FDA should
consider the nature of this information and its place within First
Amendment jurisprudence. We would like to suggest to FDA that this type
of speech is *not* commercial speech. As PhRMA's comments explained:

> \[W\]hen researchers affiliated with a company publish study findings
> in a medical or scientific journal, the publication should not be
> considered commercial. Other examples of at least presumptively
> non‑commercial speech include medical and scientific information
> provided in response to unsolicited requests for the information, the
> exchange of scientific data at scientific meetings, and
> non‑promotional press releases announcing research findings.[^32]

We agree that the above‑described speech is not proposing a commercial
transaction. Moreover, this type of speech is at the heart of First
Amendment protection. Free dissemination of scientific and technical
information often has the potential to directly advance the quality of
medical care. Indeed, it is difficult to underestimate the importance of
a free and open dialogue among the producers of medical technology,
those who apply that technology, and those who need that technology.
This is the type of speech that must be protected at all costs, and we
are convinced that it is imperative that FDA reconsider its stance on
scientific and technical speech.

We both agree and disagree with the comments of the Public Citizen
Health Research Group ("Public Citizen"), which argued that
"\[g\]overnment must play an active role in proctoring the information
drug and medical device manufacturers provide to physicians and patients
because the incentives for the manufacturers to distort the 'truth' by
providing the public a misleading, one‑sided presentation of the
scientific evidence, are enormous."[^33] While we disagree with their
assertion of the incentives to distort the truth (see part IV above), we
agree that FDA has a role to proctor the information. As the industry
regulator, FDA does and should continue to serve the function of
policing and enforcing the rules requiring truthful information. But the
proctoring role does not include censoring truthful information, and
that is what the First Amendment prohibits FDA from doing.

## FDA Should Not Regulate the Dissemination of Peer‑Reviewed Materials Based upon Who Is Communicating the Information.

We believe FDA's present limitations on *who* may disseminate
peer‑reviewed materials are unconstitutional. As we understand it, FDA
prefers that sales representatives not be allowed to disseminate
information pertaining to off‑label uses. We question the
constitutionality of such a distinction in light of the Supreme Court's
expressed reservations about regulations that use the identity of the
speaker to regulate speech. For example, the Court has explained that
"\[t\]he inherent worth of the speech in terms of its capacity for
informing the public does not depend upon the identity of its source,
whether corporation, association, union, or individual."[^34] Thus,
"\[i\]n the realm of protected speech, the legislature is
constitutionally disqualified from dictating the subjects about which
persons may speak and the speakers who may address a public issue."[^35]

Scientific and technical information about off‑label uses is protected
speech, regardless of who distributes it. Thus, FDA's distinction that
separates sales representatives from other company personnel simply does
not pass constitutional muster. As explained above, because this speech
is constitutionally protected, FDA cannot dictate which speakers may
disseminate the information. Moreover, as a practical matter, we note
that in many organizations, no clear line exists between "sales
representatives" and "headquarters personnel." Thus, such a distinction
is overly vague and unenforceable, as it would not be possible to tell
who could engage in speech and who could not.

# FDA Should Develop Clear Policies that Encourage the Free Flow of Information.

As a general matter, we encourage FDA to assess its stance on commercial
speech in light of its mission, which is not only to protect public
health, but also "to *promote* the public health by . . . taking
appropriate action on the marketing of regulated products in a timely
manner."[^36] We believe, as do many other individuals and organizations
commenting, that FDA may better fulfill this charge by promoting the
free flow of truthful and non‑misleading information among the medical
community.

Unfortunately, ambiguous FDA regulations and policies on commercial
speech may unintentionally help unethical companies thrive. When FDA
adopts rules that prohibit otherwise constitutional conduct, ethical
companies, out of respect for the agency and concern for their
reputation, abide by the agency's regulation. In our experience, ethical
companies almost always make a conscious decision to abide by the
agency's decision and to not exploit an ambiguity or potential
unconstitutionality. Other companies, however, do not hold themselves to
such standards. For whatever reason, whether they are unethical or
simply desperate to survive in a competitive market, some companies
seize upon ambiguity and exploit any possible advantage.

This harms both FDA and the public that FDA is charged to protect. In
our experience, when this occurs, FDA may not bring an enforcement
action because it recognizes the ambiguity. This has the effect of
helping unethical or "fly by night" companies to flourish, which clearly
does not benefit the public. And it simultaneously disadvantages ethical
companies, which in turn stunts the development of quality products that
benefit the medical community and public.

Clarification of FDA policies will help to avoid this problem. In
particular, if FDA develops unambiguous policies and regulations,
companies that may have formerly been able to exploit FDA's policies
will be forced to adhere to FDA policy. Any violations will be clear,
and FDA will therefore be in a better position to bring---and win---an
enforcement action. Clearly, unambiguous and constitutional regulations
and policies will have a direct benefit to the public.

\* \* \* \* \*

Conclusion

Over the last 30 years, sources of drug and device‑related information
have shifted dramatically. Formerly, medical schools were the driving
force behind all medical research, including research related to
pharmaceuticals and devices. In recent years, however, partly because of
the escalating costs of such research, the device and pharmaceutical
industries themselves have driven the research related to their products
and have sponsored research at a wide variety of institutions. In
addition, industry is now the source of a wide range of original
research and employs highly skilled professional staff with scientific
credentials on par with many academic settings. Thus, the device and
pharmaceutical industries have become a principal source and repository
of device and pharmaceutical information.

The irony of FDA's current regulatory approach toward device and
pharmaceutical information is that those individuals with arguably the
*most* information can say the *least*, and that those responsible for
caring for patients are treated as unsophisticated consumers.

Equally troubling is the fact that FDA's policy encourages
misinformation to go unchallenged. For a variety of reasons, FDA does
not have jurisdiction over those outside of the chain of distribution
for devices and pharmaceuticals. As a result, given the fast‑changing
means by which information can be disseminated, there are significant
amounts of largely unregulated device and pharmaceutical information
disseminated each day through vehicles such as the Internet. Much of it,
by any standard, is of questionable quality. But device and
pharmaceutical companies cannot rebut much of the misinformation that
enters the marketplace from unregulated sources unless they have
information that meets the approval standard test or unless first
specifically asked.

As the FDA proceeds with its review, it is imperative that the agency
keep in mind the extraordinary value of the information its regulations
currently impede. We appreciate this opportunity to add our concerns to
the comments that were previously submitted in response to FDA's request
and applaud FDA's efforts to ensure that its regulations, policies, and
procedures are consistent with the First Amendment.

Respectfully submitted,

![](media/image1.wmf)

Bradley Merrill Thompson

Secretary and General Counsel

Indiana Medical Device Manufacturers Council

BMT/slb

[^1]: Schering‑Plough, Comments to FDA, p. 3 (Sept. 13, 2002)
    (hereinafter "Schering‑Plough").

[^2]: *Id*.

[^3]: *Id*. (emphasis added).

[^4]: Congress of the United States, Comments to FDA (Sept. 13, 2002)
    (hereinafter "Congress").

[^5]: Congress, *supra*, at 20‑21.

[^6]: *Id*. at 20.

[^7]: *Id*. at 21.

[^8]: Johnson & Johnson, Comments to FDA, p. 7 (Sept. 13, 2002)
    (hereinafter "Johnson & Johnson").

[^9]: 21 C.F.R. § 314.81 (2002).

[^10]: Telephone Interview with National Library of Medicine, Bethesda,
    Maryland (Oct. 18, 1995).

[^11]: Section 502(a) addresses misbranded drugs and devices.

[^12]: V.E. Irons, Inc. v. United States, 244 F.2d 34 (1st Cir. 1957),
    *cert. denied*, 354 U.S. 923 (1957); United States v. 23, More or
    Less, Articles, 192 F.2d 308, (2d Cir. 1951); United States v.
    Vrilium Prods. Co., 1938‑1964 F.D.L.I. Jud. Rec. 944 (N.D. Ill.
    1950), *aff'd*, 185 F.2d 3 (7th Cir. 1950), *cert. denied*, 340 U.S.
    947 (1951).

[^13]: *E.g.,* United States v. Hoxsey Cancer Clinic, 198 F.2d 273
    (5th^ ^Cir. 1952), *cert. denied*, 344 U.S. 928 (1953);
    United States v. Articles of Drug, 263 F. Supp. 212 (D. Neb. 1967);
    United States v. Vitamin Indus., Inc., 130 F. Supp. 755 (D. Neb.
    1955); United States v. Ten Cartons, More or Less, 1938‑64 F.D.L.I.
    Jud. Rec. 1519 (1957).

[^14]: Prescription Drug Product Labeling Medication Guide Requirements,
    60 Fed. Reg. 44,182 (Aug. 24, 1995).

[^15]: 21 C.F.R. §§ 310.501, 310.515 (2002).

[^16]: Prescription Drug Products; Patent Package Insert Requirements,
    45 Fed. Reg. 60,754 (Sept. 12, 1980), cmt. 7.

[^17]: *Id.* at cmt. 1.

[^18]: Advanced Medical Technology Association, Comments to FDA,
    pp. 10‑11 (Sept. 13, 2002) (hereinafter "AdvaMed").

[^19]: *E.g.*, Letter from HHS, FDA, CDRH, to Peter Klein, Chief
    Executive Officer, Diomed Incorporated (Nov. 5, 2001) (on file with
    FDA); Letter from HHS, FDA, CDRH, to Fred Hassan, Chief Executive
    Officer, Pharmacia & Upjohn (Sept. 21, 2001) (on file with FDA);
    Letter from HHS, FDA, CDRH, to Kenneth Anstey, President and CEO,
    Oratec Interventions, Incorporated (Aug. 17, 2001) (on file with
    FDA).

[^20]: *E.g.*, Food Lion, Inc. v. Capital Cities/ABC, Inc., 194 F.3d 505
    (4th Cir. 1999) (disallowing plaintiff to recover damages for
    reputation‑related claims that satisfied state law requirements but
    that did not satisfy the higher standards of the First Amendment).

[^21]: Pharmaceutical Research and Manufacturers of America, Comments to
    FDA, p. 23 (Sept. 13, 2002) (hereinafter "PhRMA").

[^22]: 21 U.S.C. § 360k(a) (2002).

[^23]: 21 C.F.R. § 808.1(b) (2002).

[^24]: Duvall v. Bristol‑Myers‑Squibb Co., 103 F.3d 324, 332 (4th Cir.
    1996); *see also*, Martin v. Telectronics Pacing Sys., Inc.,
    105 F.3d 1090, 1100 (6th Cir. 1997). Although the Supreme Court has
    held that section 360k does not preempt certain state law claims,
    federal courts, as explained, have subsequently affirmed that state
    express warranty claims are not within the scope of the Court's
    holding. Medtronic v. Lohr, 518 U.S. 470 (1996).

[^25]: *E.g.*, Friedman v. Medtronic, 345 N.Y.S.2d 637 (N.Y. Sup. Ct.
    1973).

[^26]: *See* Martin, 105 F.3d at 1101.

[^27]: *See* Comments of the Staffs of the Bureau of Economics and
    Consumer Protection of the Federal Trade Commission before the
    Department of Health and Human Services Food and Drug Administration
    in the matter of Pharmaceutical Marketing and Information Exchange
    in Managed Care Environments; Public Hearings at 11 \[Docket
    No. 95N‑0228\] (Jan. 16, 1996).

[^28]: 15 U.S.C. § 1051 *et seq.* (2002).

[^29]: *E.g.*, Allen v. G.D. Searle & Co., 708 F. Supp. 1142 (D. Or.
    1989); Grinnell v. Charles Pfizer & Co., 79 Cal. Rptr. 369 (App.
    1969); Toole v. Richardson‑Merrell, Inc., 60 Cal. Rptr. 398 (App.
    1967); Tetuan v. A.H. Robins, 738 P.2d 1210 (Kan. 1987).

[^30]: A manufacturer might also expose itself to state law claims for
    negligent misrepresentation, if a purchaser relies on the
    representations or "overpromotions." *E.g.*, Fane v. Zimmer,
    927 F.2d. 124, 130 (2d Cir. 1991).

[^31]: Holley v. Burroughs Wellcome Co., 348 S.E.2d 772 (N.C. Sup.
    1986); *see also* Stevens v. Parke Davis & Co., 507 P.2d 653, 661‑62
    (Cal. 1973).

[^32]: PhRMA, *supra*, at 5.

[^33]: Public Citizen Health Research Group, Comments to FDA, p. 3
    (Sept. 13, 2002) (hereinafter "Public Citizen").

[^34]: First Nat'l Bank of Boston v. Bellotti, 435 U.S. 765, 777 (1978).

[^35]: *Id*. at 784‑785.

[^36]: 21 U.S.C. § 393(b) (2002) (emphasis added).