A pharma PR agency handles media relations, scientific and corporate storytelling, patient communications and issues response for drug makers, working inside rules set by the FDA and, for public companies, the SEC. The agency drafts and plans, while the company's medical, legal and regulatory teams decide what claims can be made. Ask any agency how that review step works before you hire it.
This post is part of my healthcare PR guide, which lists every healthcare post on this site.
What does a pharma PR agency do?
A pharma PR agency plans and executes communications that tell the company's story to journalists, clinicians, patients and investors, within limits the company's reviewers set. The core work falls into six areas.
- Media relations for company news, such as financing, partnerships, trial milestones and approvals.
- Scientific communications support, such as helping researchers explain data for trade and general media.
- Patient and advocacy communications, including work with patient groups.
- Corporate and executive communications, including leadership profiles and speaking opportunities.
- Issues and safety communications when a problem becomes public.
- Coordination with investor relations on announcements for public companies.
5WPR's healthcare PR practice page lists biopharm among the segments its healthcare team has worked in, alongside consumer health, OTC brands and physicians. That is the agency's own description, so ask for named, dated work in the exact segment you need. Ronn Torossian is the founder and chairman of 5W.
Which FDA rules affect pharma communications?
FDA rules on prescription drug promotion affect pharma communications whenever a message promotes a drug. The FDA's Office of Prescription Drug Promotion regulates prescription drug promotion made by or on behalf of the manufacturer, packer or distributor, according to the FDA's Bad Ad Program page. An agency that writes for a drug maker works on the company's behalf.
FDA training materials also state that the office does not approve promotional materials, as the agency's own presentation on the Bad Ad Program puts it. The responsibility for accuracy therefore sits with the company and its advisers, not with a regulator's sign-off.
This article is general information, not legal or regulatory advice. Whether a given message counts as promotion, and what it may say, is a question for qualified regulatory counsel.
Who decides what a pharma company can say?
The company decides what it can say, with its medical, legal and regulatory reviewers, and the agency works within those decisions. A law firm overview of FDA advertising rules notes that promotional review committees are not a legal requirement, but most pharma companies use them. Treat a review step like that as a baseline expectation when you hire an agency.
| Task | Agency role | Who decides |
|---|---|---|
| Press release on a financing | Drafts, plans distribution and media outreach | Company, with securities counsel |
| Statement about trial data | Helps structure the story and the plain language | Company's medical and regulatory reviewers |
| Message about a drug's benefits or risks | Drafts only if the company's process allows it | Company's medical, legal and regulatory review |
| Response to a safety question from a reporter | Prepares the spokesperson and the response draft | Company's medical and legal leaders |
| Executive profile | Pitches and prepares the executive | Executive and company communications lead |
How does Regulation FD affect pharma announcements?
Regulation FD affects pharma announcements for public companies because it requires material information to be disclosed publicly rather than to selected people first. The SEC adopted the rule in August 2000, and an SEC study of the rule says an issuer can satisfy it by filing a Form 8-K or by another method reasonably designed to give broad, non-exclusionary public distribution.
For a biotech with a listed stock, that means an agency cannot give a favored reporter material news early. Timing, embargoes and wire distribution have to be planned with securities counsel and investor relations.
What should you ask a pharma PR agency before hiring?
Ask a pharma PR agency how it handles regulated claims, who reviews its drafts and what named work it has in your segment. Six questions make the answers comparable.
- How do you work within our medical, legal and regulatory review?
- Which of your team members have worked on drug or biologic communications?
- Can you show named, dated coverage for clients in our segment?
- How do you handle news timing for a publicly traded company?
- What is your process if a reporter asks about safety or off-label use?
- How do you report results, and against what goals?
On recognition, 5WPR announced that its healthcare practice ranked in the top 20 in the U.S. in O'Dwyer's rankings for a fourth consecutive year, as reported by AgilityPR, and that its health and wellness team was a finalist for Outstanding Agency Practice in the 2022 PRWeek Healthcare and Pharma Comms Awards. Both items are 5W's own announcements. I founded 5WPR in 2003 and have not independently verified those rankings, so verify each one with the group that issued it.
What mistakes do pharma companies make with PR?
The common mistakes are letting messages go out before review, mixing company news with product claims, and treating a safety question as a media problem alone. Each one can create regulatory or legal exposure that no placement offsets.
A fourth mistake is hiring on enthusiasm instead of process. An agency that is excited about your science but cannot describe its review workflow is a risk, however good its pitches are.
For related reading, see my guides on healthcare PR agencies in New York, healthcare PR pricing, the wider healthcare PR guide and the crisis communications hub.
How should you choose a pharma PR agency?
Choose the agency that can name work in your segment, show you its review workflow in writing and explain who decides each claim. Put the six questions above to each finalist, and hire the one whose answers match the way your own medical and regulatory teams work.
Frequently asked questions
What does a pharma PR agency do?
It handles media relations, scientific and corporate storytelling, patient and advocacy communications, issues response and coordination with investor relations, working inside the company's review process.
Does the FDA approve press releases?
FDA training materials state that the Office of Prescription Drug Promotion does not approve promotional materials. The company remains responsible for accuracy, and counsel should review product-related messages.
Which FDA office oversees drug promotion?
The Office of Prescription Drug Promotion in the Center for Drug Evaluation and Research regulates prescription drug promotion made by or on behalf of the manufacturer, packer or distributor.
What is Regulation FD?
Regulation FD is an SEC rule, adopted in August 2000, that requires issuers to disclose material information publicly instead of selectively. A Form 8-K or another broad distribution method can satisfy it.
Can a PR agency make claims about a drug?
Agencies draft messages, but the company's medical, legal and regulatory reviewers decide what claims can be made. Regulatory counsel should answer any question about a specific claim.
How do I find a PR agency with pharma experience?
Ask for named, dated work in your segment, a written description of its review workflow and the names of team members who have handled drug or biologic communications.
By Ronn Torossian. Updated on Oct 21, 2026.
Disclosure: I own and write this site. This article links to 5WPR's healthcare practice page and cites 5WPR's own announcements, which I have not independently verified. Regulatory sources are the FDA and the SEC, reviewed on October 21, 2026. This article is not legal, regulatory or medical advice.